What are the responsibilities and job description for the Regulatory Affairs Manager position at Katalyst Healthcares & Life Sciences?
Responsibilities:
- In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more.
- You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
- Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management.
- Lead preparation and submission of 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.
- 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 presses 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.
