For a dynamic orthopedics Medical Device scale-up, I am looking for a RA Executive that fits the spirit of an innovative company aiming to become the global leader.
The company is a pioneer and developer of solutions for targeted and controlled bone healing. Their refining technologies are game changing in the field and they’re on a mission to improve patient rehabilitation. This all plus the manufacturing takes place in a vibrant location in the Utrecht area.
In this role you’ll be involved in various RA aspects as Country Registrations, Gap Analysis to enter new markets, implementation of new standards and Regulatory Submissions.
- Be part of a well-experienced and enthusiastic RA team with a Head of QA/RA, RA Manager, QA/RA Officer and RA Assistant, which is part of a larger QA/RA department
- Technical Documentation maintenance
- Regulatory submissions for new products or extended claims (e.g. MDR Tech File, FDA 510(k))
- Country registrations in EU and internationally, Document legalisations
- Gap Analyses and implementation of new or updated standards and regulations
- Trending of complaints and production nonconformities for Post Market Surveillance
- Risk Management, Complaint handling, MDR reporting, Recalls
- Educational degree: Bachelor or equivalent
- 3+ years of experience in a similar role in the medical device, chemical or electronical industry
- Knowledge of the EU and US medical device legislation (e.g. EU-MDR and US CFR21)
- Good English skills (written and spoken)
- Accurate, pro-active, analytical, good communication skills
ORGANISATION AND OFFER
This is an entrepreneurial company and still acting as a start-up. At the same time, they are for more than 20 years, specialised in high-risk medical devices. They’ve 140 years of combined research experience amongst the team and refining technologies that are game changing in the field. This organisation is unique in what they do, with more than 80 (pending) patents.
The organisation offers an attractive salary and generous conditions.
INTERESTED? Reach out to Christian Steenkamp for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org