Regulatory Site Manager
Are you looking for great professional development opportunities?
Do you feel living close to the Mediterranean sea increases your work-life balance?
Do you love to take over responsibilities and to work in a fast-paced Start-up environment?
If you answer those questions with a definitive "oui", we would like to talk you through the role as
Regulatory Site Manager, South of FranceOur client is an awarded, well-funded start-up company, which offers an amazing position as Regulatory Site Manager. In the position you will be fully responsible for all Regulatory aspects of a class IIa device.
Within the role as RA Site Manager, you will join the company at the most exciting time. Our client successfully registered its product on the CE and US market with plans to launch new products annually and to conquer the Asian market in 2021 at the latest.
Following the intensive growth plans, you will have the opportunity to develop into the VP of Regulatory position within the first 18 months of your employment.
- Implementation of a technical Regulatory and a strategic plan for your department
- Structured management of registration processes
- Risk Management expertise following ISO14791, incl. GAP Analysis
- Develop existing Regulatory processes and proactively implement new processes where needed
- Subject Matter Expert in Regulatory Affairs for health authorities with the ability to move within grey areas and to professionally communicate with the authorities
- Representing the RA department to Management and authorities
- Disciplinary and professional heading of the Regulatory Affairs department
- Developing of Team member and Training of interdisciplinary departments (e.g. Quality, Marketing, Production…) in RA matters
- Experienced in leading a small team, in project management at least.
- Knowledge of the standards 21CFR820 (FDA), ISO13485 (CE market), ISO14791
- Being able to anticipate risks and to introduce preventive actions
- Minimum Bachelor in Bio-Engineering, Regulatory Affairs or similar education
- Mastery of MDR (EU) 2017/745
- Strategical approaches
Please contact me asap for more detailed information.
Phone: 0044 203 8000 501