I'm recruitment consultant specilised in Life sciences.
I'm currently looking for a Regulatory Affairs with medical devices experience.
The company is striving to offer high performance optical solutions, focusing on its mission, which is to improve the quality of sight, and therefore, the quality of life.
- Write, edit and review comprehensive regulatory and technical documentation, application dossiers and summaries of technical file.
- Play an active role in the definition of the registration roadmap and timelines to achieve registration strategy globally
- Support cross functional alignment initiatives to ensure compliance on Regulatory and Clinical activities
- Provide technical and product expertise to regulatory and commercial agents for the countries he / she is responsible
- Handle administratively and keep up-to-date registration files, change notification and tenders for the countries he / she is responsible
- Maintain submission and technical documentation, licenses and records up-to-date
- Maintain certification in the countries he / she is responsible
- Ensure documents are produced in accordance with applicable internal and external procedures, guidelines, regulations and standards
- Maintain day-to-day distributor relationships (Regulatory)
- Serve as contact point for regulatory operations in the countries he / she is responsible
- Report on registrations performance and progress
- MSc (or higher) degree in a technical or science discipline, Administrative degree in addition (optional)
- General knowledge of medical device regulations and Quality Management Systems
- At least 2-5 years of relevant experience within regulatory function in medical devices industry
- Experience with:
- implantable medical device technical documentation formats (for ex. IMPDRF, MDR…)
- implantable medical device registration globally
- regulatory, technical, clinical data maintenance and interpretation
- ISO 13485, ISO 14155, GMP
- Experience with FDA registration is a plus
- Ability to work across function and in an international environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Fluent English speaking, writing, reading. Other language(s) would be a benefit.
- Good computer skills (Microsoft Office package)
- Good negotiating skills
- Multitasks, ability to prioritize and conscious of lead-time.
- Strong organizational and follow-up skills, as well as attention to detail.