Regulatory Affairs Specialist
- Experience Level
- Experienced (non-manager)
To combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured and distributed to meet applicable regulatory requirements and applicable technical standards
One of the largest global medical technology companies, addressing some of the most challenging global health issues.
- Execute transition of MDD tech files to MDR Technical Documentation, monitor and report progress
- Acting as RA lead for MDR compliance projects, propose workable solutions for resolution of complex regulatory challenges, hands-on approach in driving projects to completion
- Participation in cross-functional product development teams as the regulatory lead
- Maintain high level of quality and compliance (to MDR/ MDD/ company quality systems) in technical document preparation and review & approval of various product/ project specific documentation.
- Participate to the review of process/product changes, labelling, claims, product complaints, Advertising & Promotional materials, etc., to determine the need for any regulatory activities and to ensure compliance to International requirements
- Active inputs into development and review of quality system procedures & work instructions, CERs/ PSURs and input into risk mgmt.
- Development of regulatory strategies for product release and product change assessments
- Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life cycle
- May Assess changes in regulations and helps to determine their impact
- May Attend to audits performed by internal and external authorities to represent RA positions and processes
- May support International product registrations
To be successful in this role you will have proven regulatory affairs experience within the medical technology industry or equivalent.
- You should have demonstrated compliance experience with Class IIa/IIb - MDD/MDR medical devices, including (P)EMS - (Programmable) Electrical Medical Systems
- Sound knowledge of the regulatory framework pertaining to Medical Devices such as the MDD and MDR CE Marking
- Prior working experience on MDR preferred
- Experience working with International Standards like IEC/EN 60601-1 (safety)/ 60601-1-2 (EMC)/ 62304(software)/ 62366 (usability), ISO 14971 (Risk Management) and ISO 13485 (QMS) Good working knowledge of Design Control, Software Life Cycle, Risk Mgmt, V&V processes
- Minimum of a Bachelor's degree in scientific or engineering subject area and 5+ years of regulatory Affairs experience
- You should be a hardworking teammate, agile in execution with sense of ownership, in a complex and fast evolving environment.
Competitive package available / Site + remote working / Opportunity to join a global med-tech business