summary

hong kong
HK$35,000 - HK$65,000 per year
permanent
full-time

specialism
life sciences
sub specialism
regulatory affairs
reference number
91M0264033_1987707146036401743

job details

about the company.
...

We are partnering with a high-growth biotech innovator in search of a strategic and meticulous Regulatory Affairs Specialist/Manager to lead their product registration efforts. As the company prepares for its 2026 IPO, you will play a pivotal role in securing market access for their new line of lab equipment. This is a unique opportunity for an RA professional to build a regulatory framework from the ground up within a fast-paced, pre-IPO environment.

about the job.

Define and execute the regulatory roadmap for the launch of new laboratory equipment in Hong Kong and key international markets (e.g., NMPA, CE-IVDR, FDA).

Act as the primary lead in selecting, briefing, and managing external regulatory consultants and CROs to ensure project milestones are met on time and within budget.

Coordinate the preparation and submission of technical dossiers, ensuring all internal data is translated into compliant filings for successful market approval.

Ensure all lab equipment meets ISO 13485 standards, electrical safety requirements, and other relevant quality and safety certifications.

Support the executive team by maintaining a "listing-ready" regulatory framework, ensuring all documentation meets the transparency and compliance standards required for a 2026 IPO.

Serve as the internal point of contact for government bodies and notified bodies, effectively defending the company’s regulatory positions.

Partner with R&D and Quality teams to integrate regulatory requirements into the early stages of product design and change management.

skills & experiences required.

Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related discipline.
5–8 years of experience in Regulatory Affairs within the medical device or laboratory equipment sector; experience in a startup or pre-IPO setting is a major advantage.
Proven ability to manage external consultants or third-party agencies to deliver complex regulatory outcomes.
Deep understanding of the registration process for lab equipment/IVD; familiarity with both local (DH/MDCO) and international (NMPA/FDA/MDR) frameworks.
Ability to balance immediate registration needs with the long-term compliance goals necessary for a successful public listing.

about the company.
...

about the job.

Define and execute the regulatory roadmap for the launch of new laboratory equipment in Hong Kong and key international markets (e.g., NMPA, CE-IVDR, FDA).

Act as the primary lead in selecting, briefing, and managing external regulatory consultants and CROs to ensure project milestones are met on time and within budget.

Coordinate the preparation and submission of technical dossiers, ensuring all internal data is translated into compliant filings for successful market approval.

Ensure all lab equipment meets ISO 13485 standards, electrical safety requirements, and other relevant quality and safety certifications.

Support the executive team by maintaining a "listing-ready" regulatory framework, ensuring all documentation meets the transparency and compliance standards required for a 2026 IPO.

Serve as the internal point of contact for government bodies and notified bodies, effectively defending the company’s regulatory positions.

Partner with R&D and Quality teams to integrate regulatory requirements into the early stages of product design and change management.

skills & experiences required.

Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related discipline.
5–8 years of experience in Regulatory Affairs within the medical device or laboratory equipment sector; experience in a startup or pre-IPO setting is a major advantage.
Proven ability to manage external consultants or third-party agencies to deliver complex regulatory outcomes.
Deep understanding of the registration process for lab equipment/IVD; familiarity with both local (DH/MDCO) and international (NMPA/FDA/MDR) frameworks.
Ability to balance immediate registration needs with the long-term compliance goals necessary for a successful public listing.

skills
no additional skills required
qualifications
no additional qualifications required
education
Bachelor Degree

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boris ho

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regulatory affairs manager/specialist | medical devices.

job details

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the application process.

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we’ll give you a call.

getting you registered.

compliance check.

reference and background check.

the perfect job for you.

the interview.

start your new job.

get in touch

boris ho

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