For a leading Medical Device client I'm looking for a Senior Regulatory Specialist with minimum of 5 years of experience in the medical device industry and technical environment.
- Work according the business applicable processes and as ambassador of the company values.
- Train regulatory resources in their development.
- Exercise supervision in terms of schedules, methods and staffing for projects leading
- Establishes operational objectives and work plans, and delegates assignments to project team members.
- Keeps abreast of current regulatory procedures and changes
- Key role in external and internal audits related to product submission such as FDA, MFDS, NMPA etc. and notified body audits.
- (support)Reviews and recommends changes for labeling, and clinical protocols to maintain regulatory compliance.
- Responsible for developing and implementing global regulatory and roadmaps though deep understanding of the competitive market landscape , regulatory/ legislative initiatives, and product marketing strategy for their responsible products within IGT-S Fixed portfolio
- Responsible for product registrations/approvals in her/his field.
- Leads regulatory resources as part of projects (s)he works in.
- Minimal of 5 years of experience in the medical device industry and technical environment with at least 3 years in an Imaging Diagnostic medical device company( FDA Class II equivalent – Class III a plus)
- Must have experience with successful preparation and submission of 510 (k) , PMA or international documents or registration and marketing of medical devices worldwide
- Strong background in Design Controls
- Excellent working knowledge of Standards like IEC62304/82304/60601
- Excellent working knowledge of medical device regulations (21CFR), FDA Law, MDD, MDR, other global laws and regulations.
- Experience in supporting international registrations and clinical investigations(as a plus)
- Bachelor’s degree in a technical/quality/law/pharma discipline
- RAPS certified(as a plus)
- Duration: 6 months - high chance of extension
- Start date: ASAP
- Location: Best
If you are interested in the above description, apply with your CV
PS: Did you also know that we offer an attractive referral scheme?
For more information please contact Selin Ozbeden on +31 (0)20 20 44 502