Hobson Prior are looking for RA R&D Project Manager to join a leading medical research and development organisation who are focused on the well-being of patients all around the world.You will support the Regulatory Diagnostics team for registration of Software as Medical Device and Companion Diagnostics in the EMEA region.
- Prepare or review regulatory strategies and plans for Medical Devices and In Vitro diagnostics.
- Complete regulatory assessments for product qualification as medical device.
- Create or review Technical Files and design dossiers for submission in EMEA.
- Coordinate product regulatory GAP assessments against MDR 2017/745 and relevant harmonized standards.
- Coordinate responses to requests from notified bodies and regulatory authorities in order to expedite approval of regulatory submissions.
- Assess regulatory impact of product changes.
- Co-operative team-player with a dynamic personality.
- Strong verbal and written communication skills.
- Detail oriented regulatory leader.
- Bachelors, preferably Masters, degree in biochemistry, microbiology, pharmacy or life-science or health-related discipline with minimum 10 years business experience.
- A minimum 10 years’ experience with regulatory strategies and EU conformity assessments for molecular In Vitro Diagnostics (IVD Dir 98/79/EC) and Medical Devices (Dir 93/42/EEC).
- Understanding of design controls, software development process, computer system validation and cybersecurity.
- Familiar with development of PCR tests or next gen sequencing, validation and performance characteristics of such test, clinical validation protocols and reports.
- Proficient use of digital technology.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.