Senior Regulatory Affairs Specialist
Our client a world class medical consumables and device manufacturer are looking for a Senior Regulatory Specialist responsible for the overall product safety and regulatory compliance of at the manufacturing site.
The Senior Regulatory Affairs Specialist will ensure product compliance, maintain and update medical device regulatory filing including product registrations and Technical Documentation. In addition, the Senior Regulatory Affairs Specialist will drive Post Market Surveillance activities and will act as a regulatory consultant for other functions to ensure regulatory compliance across all products and processes.
- Ensure availability of up-to-date Design History Files for regulated products
- Prepare, submit and manage regulatory filings required for product market approvals as necessary
- Function as a RA subject matter expert on new product introduction and engineering design control teams
- Support post market surveillance activity including assembling necessary evidence and prepare Summary reports as appropriate
- Support potential MDR, Vigilance and Recall investigations to conclusion and prepare and file necessary MDR, Vigilance, Recall reports
- Provide regulatory input to QA in Deviations, CAPAs and complaints
- Provide guidance regarding regulatory and performance test requirements such as biocompatibility and sterility
Experience and qualifications:
- Medical Devices or Biotechnology or Life Sciences industry experience, working in Regulatory/Quality or an applicable Technical field.
- IVDR implementation
- Working knowledge of ISO 13485 and regulatory requirements for medical devices (including IVDD 98/79/EC, FDA CFR 21 part 820, CMDR
- biocompatibility testing and extractable and leachable testing is highly desirable but not a deal breaker
- knowledge of EN ISO 14971:2012 and Risk Management techniques (health hazard evaluation, fault tree analysis, dFMEA, pFMEA etc) for medical devices is a plus
- post market surveillance activities and familiar with test methods, sampling plans and standard for the design, verification and validation of medical device products (including sterilization, biocompatibility and packaging validation) is a plus.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales