What Jobs are available for Inspection Manager in Hong Kong?

Responsibilities

• Inspect audit working papers to assess the degree of compliance with the professional standards.
• Meet and interview firm personnel to understand the firm's quality management system and the related impact on quality audit.
• Prepare reports on inspection findings.
• Communicate results of inspection with the audit firms.
• Fulfil other responsibilities as assigned.

Requirements

• Certified Public Accountant registered with Hong Kong Institute of Certified Public Accountants , or a member of an accountancy body that is a member of the International Federation of Accountants.
• Solid technical background, with at least 3-years post-qualification audit experience.
• Extensive professional knowledge in financial reporting and auditing.
• Experience in quality assurance will be an advantage.
• Excellent command of written and spoken English and Chinese.
• Strong organisational and project management skills, and ability to prioritise work effectively.
• Proactive, with a strong sense of responsibility, detail-minded, strong analytical and problem-solving skills, able to work independently and handle multiple tasks.
• Ability to work constructively with colleagues across the organisation.
• Strong interpersonal and communication skills.

A competitive package will be offered to the successful candidates. Applications should be sent to: The Human Resources and Administration Manager, Accounting and Financial Reporting Council, 10/F Two Taikoo Place, 979 King's Road, Quarry Bay, Hong Kong or by clicking the apply button.

Data held by the AFRC relating to employment applications will be kept confidential and used for recruitment purposes only. Applicants who are not contacted within six weeks may consider their applications unsuccessful. The AFRC will retain their applications for a maximum of one year.

Responsibilities

• Inspect audit working papers to assess the degree of compliance with the professional standards.
• Meet and interview firm personnel to understand the firm's quality control system and the related impact on quality audit.
• Prepare reports on inspection findings.
• Communicate results of inspection with the audit firms.
• Fulfil other responsibilities as assigned.

Requirements

• Certified Public Accountant registered with Hong Kong Institute of Certified Public Accountants , or a member of an accountancy body that is a member of the International Federation of Accountants.
• Solid technical background, with at least 3-years post-qualification audit experience.
• Extensive professional knowledge in financial reporting and auditing.
• Experience in quality assurance will be an advantage.
• Excellent command of written and spoken English and Chinese.
• Strong organisational and project management skills, and ability to prioritise work effectively.
• Proactive, with a strong sense of responsibility, detail-minded, strong analytical and problem-solving skills, able to work independently and handle multiple tasks.
• Ability to work constructively with colleagues across the organisation.
• Strong interpersonal and communication skills.

A competitive package will be offered to the successful candidate.

To submit your application, please click "Apply".

Data held by the AFRC relating to employment applications will be kept confidential and used for recruitment purposes only. Applicants who are not contacted within six weeks may consider their applications unsuccessful. The AFRC will retain their applications for a maximum of one year.

Our client, a US multinational conglomerate operating in the fields of industry, work safety, healthcare, and consumer goods, who is looking for a Regulatory Affairs Associate.

The Impact You'll Make in this Role?

As a Regulatory Affairs Associate, you will have the opportunity to collaborate with some of the most innovative and diverse people around the world. Here you will make an impact by:

• Preparing regulatory submission documents to authority for Wholesale Dealer License and product registration.
• Supporting authority request and responding to authority enquiries for license application and maintenance.
• Collaborating with global and cross-functional team to manage open requests and deficiencies.
• Other ad-hoc tasks as assigned by manager.

(This position is a full-time position with 1-year contract period, with the possibility to renewal subject to mutual agreement)

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor's Degree holder in Pharmacy, Science, Engineering or any health care-related discipline.
• At least 2 year of experience in regulatory affairs role in pharmaceutical, medical device or health care industry.
• Additional qualifications that could help you succeed even further in this role include:
• Sound knowledge of local regulatory environment and regulations.
• Good command of both written and spoken English and Chinese, both Cantonese and Mandarin.
• Excellent computer literacy, good interpersonal, communication and project management skills.
• Team player with high degree of integrity and responsibility. Organized, detail-minded and flexible.

Details

• Mon – Fri, 9am – 6pm, Kowloon Bay
• Tentative package: Annual leave, Medical Insurance, Paid Sick Leave, MPF

To apply for this position,  please simply click on the "APPLY" button or send your full resume to in word format indicating the job title.  If you are not contacted by our consultants within 2 weeks, please consider your application unsuccessful. All applications will be treated in strict confidence, and used for recruitment purposes only in accordance with PERSOLKELLY Hong Kong Limited's Privacy Notice.

PERSOLKELLY Hong Kong Limited: Employment Agency License No. 79017

PERSOL Hong Kong: Employment Agency License No. 79006

Key Roles and Responsibilities

• Liaise closely with internal departments and external stakeholders on upcoming changes to regulations, pharmaceutical products and medical devices;
• Coordinate the timely registration of new pharmaceutical products and medical devices, manage change applications for products/devices and handle registration certificate renewals;
• Maintain product registration dossiers and monitor submission timelines;
• Prepare and submit technical documentation to Regulatory Authorities and assist with tender documentation;
• Handle all regulatory related matters, including the review of product packaging, promotional materials and marketing materials to meet regulatory compliance;
• Perform local batch release and support any other ad-hoc tasks as assigned by the Manager.

Qualifications and Experience

• Bachelor degree in Pharmaceutical sciences, chemistry, biochemistry, biology or related life sciences;
• 1+ years of work experience in pharmaceutical regulatory affairs is preferred;
• Excellent communication and interpersonal skills to work with people of different levels and cultures;
• Able to work independently with good organization skills, highly self-motivated and detail oriented;
• Proficiency in both written and spoken English;
• Immediately available is highly preferred.

How to Apply

You are invited to send in your application and CV stating the position with reference number JGM or mail Room , Tower 1, Millennium City 1, 388 Kwun Tong Road, Kwun Tong, Kowloon on or before 3 November 2025.

Jacobson Group Management Limited is an Equal Opportunities Employer. Personal data provided by job applicants will be used strictly in accordance with our personal data policy and for recruitment purposes only. We aim to respond to successful applicants within 8 weeks and related information will be kept in our file for up to 12 months for other suitable vacancies in our organization and thereafter destroyed.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Roche Pharmaceuticals

Who we are:
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other's differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves.
At Roche we believe life is incredibly precious. So precious that we have recently embarked on a transformational journey so that we can deliver better outcomes to more patients faster. Our world is changing, our healthcare landscape is evolving and our portfolio is transforming - we are transforming.
Imagine working for an organization which focuses on putting people at the heart of what they do. Where every single person within the organization is aligned to one main motivating force, that at the center of everything they do, and their number one priority; are patients. A place which gives every individual the autonomy and empowerment to make a difference, where you are not defined by a job title. Imagine waking up every morning feeling fulfilled, having purpose and meaning in your work.
Regulatory Affairs Partner
Purpose of the role:

• Responsible for accelerating access to Roche innovations in line with overall strategic objectives that will enable value creation for patients at lesser cost to the society
• Working with the wider team to translate the constantly evolving requirements of the Hong Kong, Macau and Greater Bay Area Regulatory environment into Roche policies, procedures, solutions and strategies that ensure compliance and maximize the value for patients.
• Coordination and preparation of document packages for regulatory submissions from all areas of the Company. Compiles materials required in submissions, license renewals and regulatory related activities

Key Responsibilities:

• Formulates and drives regulatory strategy for the responsible strategic and established products portfolio
• Coordinates the collection of documents, records, reports and data from various departments for inclusion in regulatory documents
• Helps with the preparation of submissions for product approval including NCEs, import licenses to Macau and applications to the Greater Bay Area
• Contributes towards regulatory system shaping to foster a more patient-centric regulatory environment
• Assists in the review of product labeling/advertising to ensure compliance with regulations
• Maintain procedures that ensures labeling compliance of products requiring secondary packaging
• Keeps abreast of regulatory procedures and changes in industry practices
• Duties as assigned to support the License to Operate Team and the affiliate

Who you are:
Qualifications

• 3 years of Hong Kong drug regulatory affairs experience in the capacity of a RA executive position or Associate RA manager;

  
  
• Bachelor's degree or above in a Science related discipline;

Capabilities

• Regulatory Affair Partners are Roche's primary contact with the HK Drug Office on regulatory matters, requiring the ability to work effectively cross functionally at a local level and with the global network as well as the capability to negotiate and influence externally.
• Adaptable to change and entrepreneurial in nature in order to identify opportunities, while maintaining a laser focus on ensuring compliance and therefore playing a key role in retaining Roche Hong Kong and Macau's License to Operate.
• With broad and comprehensive expertise within the Regulatory environment you will lead foundation work and partner with the business to solve complex regulatory issues that impact the chapter and/or wider business. Contributes to development of squad/chapter based strategic plans and goals. Actively contributes to the learning & development of other chapter members in the License to Operate team.

Mindset & Behaviors

• Embrace the Roche Values of Integrity, Courage & Passion
• Demonstrate Roche Leadership Commitment & Core Competencies
• VACC - Embrace and master VACC (visionary, architect, coach, catalyst) behavior
• Growth - Ability to learn and unlearn quickly, take risks and experiment, and contribute to the learning cycle by sharing knowledge with others inside and outside Roche
• Value creation - Boldly act on key decisions and opportunities and boldly stop any activity that is not adding value. Ability to say "No" to stakeholders when the value is not predictable/foreseen
• Digital - Be Innovative and drive digital transformation across organizations and industries to bring value and impact to the healthcare ecosystem
• Enterprise - Think from an enterprise level, beyond boundaries and borders, to bring the best possible outcomes to both the local health environment, and more broadly, across Roche globally

• Enablers -

• Embrace agile ways of working to facilitate the transformation journey and achieve our North Star

• Enabler mindset to leverage the internal and external networks to create value and scale impact

• Self-managed - Self-management and self-direction - altruistic in supporting the global network to embrace PAM (Purpose. Autonomy and Mastery)

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.

A bit about H&H Group

Health & Happiness (H&H) Group is a publicly traded company, with established market positions in more than 15 countries in Asia-Pacific, Europe, North America and Oceania with over 3,300 team members working across the globe. Our vision is focused on premium nutrition and lifetime wellness, backed by science. We have 3 business segments – Baby, Adult and Pet Nutrition and Care – supporting whole-family health and happiness across 7 international brands.

On our journey to making a positive difference across the world, you will work with passionate people in an innovative and collaborative organization as we inspire wellness through #PurposeLedCareers

We are passionate about our customers and community and are looking for similar-minded talent to join us As an equal opportunity employer, we care deeply about creating an inclusive workplace where our team members feel valued, respected, and empowered.

Your role within the team

Support the implementation of regulatory strategies and affairs for all products, ensuring regulatory compliance of the company's products and its license renewal etc. including ingredients, labelling, packaging, and claims, safeguarding the company's reputation with customers and regulatory agencies for the assigned markets.

Key responsibilities include

• Regulatory management of Supplement/Nutrition/OTC/Skincare products for assigned markets and categories.
• Lead and expedite the product registrations, work across internal departments including Innovation, Product Development, Quality Assurance, Operations, Commercial teams, and external parties including contract manufacturers, regulatory agents, distributors, to prepare and submit the dossier documents for authorities' approval.
• Review and approve all packaging materials, marketing and training tools to comply with local regulations
• Co-ordinate with internal departments to facilitate new product development, its commercialization and product launch.
• Develop and manage regulatory strategies. Prepare and implement the annual registration plan according to business need and dossier readiness.
• Organize and maintain regulatory database, files and tracking sheets. Ensure appropriate archiving of all relevant documentation in the appropriate systems.
• Monitor evolving regulations in target markets, providing strategic insights on upcoming changes, potential impacts, and recommended actions. Proactively identify and mitigate regulatory risks to minimize business disruptions.
• Answer customer enquiries and provide best in class solution when required.
• Serve as the key liaison between regulatory bodies and internal teams, ensuring alignment on all compliance matters.
• Collaborate cross-functionally to maintain product supply continuity while adhering to regulatory standards.
• Conduct as requested regulatory activities and any ad hoc project as assigned

Desired Skills and Experiences,

• Bachelor's degree holder in health-related science, life science; Pharmacy or Medical degree desirable
• 8+ years' experience in similar field/job function, in consumer health care products experiences will be an advantage
• A proactive problem-solver with analytical thinking, independent, fast-paced and self-driven.
• Fluent in English, Cantonese, and Putonghua (written and verbal)
• Strong interpersonal skills, with the ability to engage stakeholders at all levels
• Highly organized, resourceful, and capable of managing multiple priorities
• Have a profound understanding of food industry compliance work and possess certain industry resources
• Basic understanding of technical regulations (testing and specification) and GMP, GVP, GCP etc. is required
• Occasional travel as required
• Candidate with less experience may be considered as Assistant Manager

H&H Group believes in the benefits of a diverse and inclusive workplace and aims to reflect the varied cultures within which we exist. We are committed to providing a working environment that is free from discrimination and harassment, creating a safe and inclusive environment for all.

We encourage applications from people of all ages, nationalities, religions, racial and gender identities, sexual orientations, abilities and cultures, and our hiring decisions will be based on business needs, position requirements, and the qualifications and experience of individuals. If you require support or assistance during the application process, please notify us at the time of application and we will be sure to enable reasonable adjustments where suitable.

If you have what it takes, please apply via the online portal and we will be in touch soon. We move quickly and may fill the role prior to the application close date, so we suggest you get in touch today

Salary and benefits will be competitive and commensurate with experience. All personal data collected is for recruitment purposes only.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Roche Diagnostics

*Main Responsibilities: *

• Managing local regulatory plan in cooperation with other internal stakeholders to ensure our products are registered on timely manner and business objectives are met
• Submitting technical documentation to Regulatory Authorities and securing registration approval in a timely manner
• Maintaining product registration throughout a product's lifecycle by applying appropriate regulatory change control
• Providing Global RA with real-time information required to maintain key metrics (i.e. submission dates and approval dates for all product registrations)
• Monitoring and communicating new, upcoming & changes to regulations with local stakeholders and Global RA
• Influencing / shaping regulatory landscape/regulations where possible ("advocacy")

*Requirements: *

• A minimum of a B.S. degree in biomedical science, life science or related field, with 2-3 years health-related quality-focused and regulatory experience
• Knowledge of diagnostics is preferable
• Strong interpersonal communication skills
• Self-starter, highly motivated with attention to details
• Excellent command of written and spoken English and Chinese
• Must be able to work independently, by taking general concepts and direction to produce desirable compliant outcomes
• Ability to prioritize multiple tasks and to function effectively

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.

Job Description:

• We are seeking a highly skilled professional with a medical background to coordinate and manage multi-center clinical trials, ensuring compliance with ICH-GCP and Hong Kong/Mainland regulations. This role requires regular travel between Hong Kong and Mainland China to oversee trial execution and stakeholder collaboration.

Responsibilities:

1. Regulatory Strategy & Submissions
   
   • Lead NMPA registration processes for medical devices, including product classification, technical documentation preparation (e.g., risk assessment, clinical evaluation reports), and coordination with testing laboratories
   
   • Manage overseas regulatory registrations (FDA, CE, UKCA), ensuring compliance with regional requirements (e.g., FDA 510(k)/PMA, EU MDR/IVDR, UKCA technical files)
   
   • Collaborate with R&D, QA/QC, and manufacturing teams to align product development with regulatory standards
2. Quality & Compliance Oversight
   
   • Ensure adherence to ISO 13485 and GMP standards across product lifecycle, including design controls, production processes, and post-market surveillance
   
   • Conduct internal audits and support external audits by regulatory bodies (e.g., NMPA, FDA, Notified Bodies)
3. Regulatory Intelligence & Training
   
   • Monitor updates in global regulations (NMPA, FDA, EU, UK) and communicate impacts to internal stakeholders
   
   • Develop training programs for cross-functional teams on regulatory requirements and compliance
4. Cross-functional Collaboration
   
   • Liaise with external partners, including CROs, testing agencies, and regulatory consultants, to expedite approvals
   
   • Support international market expansion by addressing regional regulatory barriers

General Qualification:

Education:

• Bachelor's degree or higher in Life Sciences, Biomedical Engineering, or related fields. Advanced degrees (e.g., MSc, PhD) preferred.

Experience:

• 5+ years in medical device regulatory affairs with proven success in NMPA registrations and at least 2 FDA/CE/UK approvals;
  
  In-depth knowledge of ISO 13485, GMP, and quality system standards;

Skills:

• Proficiency in technical documentation (e.g., design dossiers, clinical evaluation plans)
  
  Strong project management and communication skills for global regulatory coordination.

Language:

• Fluency in English and Mandarin (written and spoken) to liaise with global teams and authorities

Preferred Qualifications:

• Experience with software-as-a-medical-device (SaMD) or AI-driven medical technologies Certification in regulatory affairs (e.g., RAC, CE Marking expertise)

Key Responsibilities

• Drive medical device regulatory submissions in accordance with relevant regulations and company's strategy
• Ensure that submissions are of high quality, meet all regulatory requirements and compliance with company goals and directives
• Effectively communicate and coordinate among internal and external stakeholders to achieve regulatory objectives
• Keep abreast of relevant regulations, guidelines and industry practice
• Provide training and guidance to internal teams on regulatory requirements and procedures, including new and upcoming changes
• Ensure all regulatory files are archived and maintained in accordance with company SOPs
• Ensure QMS requirements on regulatory-related matters are fulfilled
• Review marketing materials and labelling to maintain compliance with global and internal requirements

Supportive responsibilities

• Contribute to regulatory research and strategy planning of new pipelines
• Support other regulatory topics in collaboration with cross-functional team, e.g. R&D, Quality, Business Development, Marketing etc.

Requirements

• Bachelor's degree or higher in life science, engineering or related fields
• At least 5 years regulatory affairs experience with track record in obtaining Class II or above electronic medical device approval in US, EU or China, preferably with ultrasound devices
• Extensive knowledge and experience in global medical device regulations, requirements and standards, such as US 510(k), De Novo, FDA QSR, EU MDR, ISO 13485, IEC 60601, ISO 14155, ISO 14971, ISO 62304, and other technical standards applicable to electronic / ultrasound devices
• Experience in working with multiple cross disciplines in preparing device submission files, e.g. R&D, Manufacturing, Quality, etc.
• Experience in working with external vendors in various disciplines, such as regulatory consultants, local distributors, contract manufacturers
• Candidate with more experience will be considered as Regulatory Affairs Manager, whilst less experience will be considered as Associate Regulatory Affairs Manager
• Excellent verbal and written communication skills in English, Cantonese and Mandarin
• Proficient in MS Office, including Word, Excel and Powerpoint
• Proactive communication and interpersonal skills
• Project management and organization skills
• Attention to detail, analytical abilities and problem-solving skills
• Ability to translate complex regulatory guidelines into simple context and effectively educate cross department stakeholders with diverse background
• Adapted to dynamic working environment and motivated to acquire new knowledge continuously

Benefits

• Medical and dental insurance (Covering spouse and children)
• 5-day Work Week
• Min. 14 Annual Holidays
• Enjoy Special Leave: Birthday Leave, Study Leave, Family Leave, Marriage Leave, Pawternity Leave, etc.
• Fun working culture with challenges to learn and grow together
• Employee Wellness and Support Group

To apply, please send your resume together with present and expected salaries with contact details via email to: Opharmic Technology (HK) Limited, Attn: Ms. Zeta Hung,  

About Opharmic

Founded in 2016, Opharmic is striving towards an ambitious goal: to replace horrifying eye injections around the world with our patented non-invasive ultrasound system. From technology and product customisation, to clinical development and regulatory strategies, Opharmic offers turnkey solution to pharma partners around the world to adopt cutting-edge technology in their new or existing pipelines.