Regulatory Affairs Manager Medical Device (remote-based)
- Experience Level
Hobson Prior are in search for a Regulatory Affairs Manager Medical Device to join a global leader within diagnostic solutions, who have a robust product portfolio and an excellent pipeline of future products. This exciting position will be focused on project support for digital products.
- Accountable to offer qualification and classification of the development object and related submission strategy.
- To review project related regulatory issues.
- To support the R&D Project teams with the applicable Design Control procedures.
- Provides team members ad hoc specific education.
- Confirm the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.
- Update Global Regulatory Affairs Business areas about changes.
- Update Global Regulatory Affairs Business areas about relevant issues during product development and life cycle management.
- To review labelling.
- You will need to collaborate with the RA-FL for submission plans, strategies and support.
- To collect the documents and the project deliverable for the preparation of worldwide registration and resolution of possible conflicts.
- Keep up to date with administration of Product declarations, Certificates and other, similar documents.
- Provide support for specific topic/questions.
- Monitor regulatory requirements, including communication and distribution in a level appropriate manner.
- Any other assigned duties.
- Excellent communications and negotiations skills.
- Fluency in Spanish.
- Educated at a master degree in engineering or programming degree.
- Excellent knowledge and understanding of RWD.
- At least 3 to 4 years' experience in hands-on global regulatory affairs.
- Previous experience in global regulatory affairs working on development projects in medical devices.
- Strong knowledge in the use of software.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.