Sr. Regulatory Affairs Specialist

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join Thermo Fisher Scientific as a Regulatory Affairs Specialist III and contribute to ensuring compliance with global regulations while enabling our mission to make the world healthier, cleaner, and safer. You'll provide strategic regulatory guidance and expertise for product development, registration, and lifecycle management across our diverse portfolio. Collaborate with cross-functional teams to develop and implement regulatory strategies that enhance time-to-market while maintaining the highest standards of compliance. Serve as a key liaison with regulatory authorities, internal stakeholders, and external partners to achieve successful outcomes.

Sr. RA Specialist - Job Responsibilities:

• Responsible for IVDs and medical devices listings with Hong Kong Department of Health under MDACS, including but not limited to execution of registration strategy, preparation of registration documents, communication with Hong Kong authority.
• Monitor changes in Hong Kong medical device regulations and update listing documentation accordingly.
• Ensure IVDs and medical devices meet Hong Kong authority regulatory requirements throughout their lifecycle, supports market entry, and acts as a bridge between legal manufacturer and regulatory authorities.
• Research and interpret regulations related to IVDs and medical devices, tracking updates to regulations, guidelines and standards, and communicating promptly with the manufacturer for the impact and updates. 
• Responsible for post-market surveillance of listed IVDs and medical devices based on related regulations and company SOPs.
• Ensure quality documentation meets both company standards and Hong Kong regulatory requirements.
• Participate in internal and external audits (regulatory and quality audits).
• Coordinate quality training and compliance awareness for local teams.

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Biomedical Engineering, or related field.
• 2+ years of experience in regulatory affairs for IVDs or medical devices, preferably with exposure to Hong Kong MDACS.
• Exceptional communication abilities and a proactive approach to achieving outcomes.
• Strong problem identification, analysis, and solution-providing abilities.
• Project management and multitasking under tight deadlines.
• Strong written and spoken English; Mandarin is a plus.