Regulatory Affairs Manager

Responsibilities

• Lead regulatory strategies, product submissions, and a team of regulatory affairs professionals.
• Work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access.
• Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management.
• Prepare and submit technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies.
• Oversee and coach a team of regulatory professionals to support both strategic and operational objectives.
• Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.).
• Define and execute submission strategies to meet timelines and business goals.
• Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review.
• Monitor changes in international regulatory environments and communicate impacts to internal teams.
• Represent the company in industry groups or regulatory associations, where appropriate.
• Support training and knowledge-sharing on country-specific regulatory requirements within the organization.

Requirements

• Bachelor's degree and/or master's in biology, chemistry, bio-engineering, or related scientific area.
• 5 years of medical device IVD Regulatory Affairs experience to include either 510(k) or PMA Notified Body (NB) submissions.
• Preference would be a former regulatory agency reviewer or staff (e.g. FDA submission reviewer).
• Proficient in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
• Experience in direct communication with regulatory agencies.
• Regulatory review experience of promotional marketing materials, press releases, labelling, etc.
• Strong oral and written communication skills as well as the ability to provide scientific presentations!
• Ability to compile data and summarize results.
• Continuous improvement minded, familiar with balancing Quality and the need for efficiency.