Regulatory Affairs Specialist

Geplaatst:

Beschrijving

Our customer’s Quality Assurance and Regulatory Affairs team is looking for a
new team member that fits the spirit of an innovative company aiming to become the global leader in
ortho-biologics.

Essential duties and responsibilities

As an enthusiastic and well-experienced multitasker in the RA domain you will be involved in various
activities at our RA team, more specifically:
• Country registrations in EU and internationally
• Preparing and maintaining regulatory submissions (e.g. MDR technical files, FDA 510k) to the
relevant authorities
• Support (new/modified) product development projects with RA input, to assure regulatory
requirements are properly addressed and implemented
• Review of promotional materials
• Complaint handling and vigilance reporting
• Trending of complaints and product related nonconformities
• Ensuring compliance and implementations of new or updated standards and regulations
• Participate in product and process Risk Management activities
• Compiling and maintaining post market related documents (PMS, PMCF, SSCP, PSUR)
• Evaluate changes with respect to compliance with regulatory requirements
You will work in a team with RA professionals (Head of Quality and Regulatory Affairs, RA Manager,
Sr. Regulatory Affairs Expert, QA/RA Officers) which is part of a larger QA/RA department.

Skills and abilities desired

• Educational degree: Bachelor or equivalent
• 3+ years of experience in a similar role in the medical device industry
• Knowledge of the European and US medical device legislation (e.g. EU-MDR, ISO 13485US
CFR21 regulations)
• Must be able to work well independently, as well as being able to work cooperatively in a team
of professionals
• Good English skills (written and spoken)
• Accurate, pro-active and analytical
• Good interpersonal and communication skills

Solliciteer op: Regulatory Affairs Specialist

CV & Motivatie (max. 3 bestanden: doc, docx, pdf, jpg)
For our medical device customer specialized in ortho-biologics for spinal fusion surgery we are searching for an experienced RA Specialist. Interested? Please react!