Job Description

Our client, a leading organization in health engineering is seeking Regulatory Affairs Specialist/ Manager to oversee compliance and regulatory strategies for driving innovative advancements in medical research and development for their products commercialization.  This role offers unparalleled career growth opportunities, focusing on regulatory excellence in cutting-edge medical technologies and therapeutic solutions. If you are motivated to contribute to pioneering healthcare innovations and excel in the regulatory landscape, this position presents an exceptional pathway for you.

Key responsibilities

• Drive medical device registrations and variations in accordance with relevant regulations (NMPA/ FDA/ CE/ UKCA) and develop regulatory strategy to obtain the product approval within target timeframe; Including risk assessment, clinical evaluation report and coordination with testing laboratories 
• Develop and implement strategic plans to secure product approvals within the desired timeframe.
• Keep abreast of regulatory procedures and product changes
• Effectively communicate and collaborate with multifunctional and R&D team in order to develop Regulatory Strategies for product commercialization
• Provide local regulation intelligence to internal stakeholders 
• Maintain registration database
• Support other regulatory topics in collaboration with cross-functional team, e.g. commercial, marketing and supply chain etc.

• Ensure company’s products comply with the regulations
• Plan and coordinate products changes with related departments 
• Ensure validation of promotional materials in compliance with local regulations and corporate policy. 
• Maintain accurate information in product labelling by collaborating with multifunctional teams and ensure compliances with local and responsible countries regulations (ISO13485 and GMP standards)

Key Requirements:

• Educational Background: Bachelor’s degree or higher in biomedical engineering or a relevant scientific discipline.
• Experience: A minimum of 3-5 years in regulatory affairs, preferably within the medical device industry, with a proven track record in international markets with at least 2 FDA/CE/UK approvals 
• Expertise: In-depth knowledge of NMPA and FDA registration processes; experience with Mainland China manufacturers and familiarity with European markets is an advantage.
• Technical Skills: Proficiency in regulatory databases and tools required for compliance and approvals.
• Passion: Genuine enthusiasm for working with cutting-edge scientific technologies and driving advancements in healthcare.
• Language Skills: Proficient in both written and spoken English and Chinese to manage diverse market needs effectively.

What to do now?  

If you are eager to contribute to meaningful advancements in healthcare sectors and thrive in a collaborative environment, we invite you to apply and become a vital part of our client's mission to improve patient outcomes. Alternatively, send your latest CV to tiffany.wong@linksinternational.com for confidential chat of your career and know more about the Hong Kong pharmaceutical market!