Johnson & Johnson
BE - Quality and Regulatory Affairs Coordinator
The Quality and Regulatory Coordinator is supporting the business AR-PRRCs and is responsible for the implementation of the procedures under the EU Medical Devices Regulation (2017/747) for Global Surgery businesses.
The Authorized Representative Quality and Regulatory Coordinator will establish the required processes in alignment with EU AR Council members across the J&J MD businesses.
DUTIES & RESPONSIBILITIES:
- AR agreement maintenance: Verification of manufacturers compliance for new MDR products certification incl. lifecycle, change and record management etc.
- Completes verification measures per process: Verifies data, notifies manufactures about gaps / required corrections and completes verification once addressed by manufactures.
- Registration of AR (Eudamed) incl. lifecycle management: Initiates and maintains registration measures per process Actor (AR) registration in Eudamed.
- Shares Single Registration Number (SRN) with manufactuers asap and with other EOs upon request.
- If informed by Importers about potential actor registration gaps or mistakes, corrects immediately if required Manages AR registration related fees and invoices if applicable.
- Verification of manufactures device data registrations (Eudamed) incl. lifecycle, change and record management etc.
- Provide regulatory and quality support to the Supply Chain End to End EU MDR Pilot Process.
- Address Economic Operators requests during the hyper care period including support and training to access relevant documents, address question and liaising with the legal manufacturer to ensure resolutions on Non conformities escalated by the Quality Organization.
- Managing CA requests incl. NC/CAPA, FSCA related.
- Supporting CA Inspections and NB audits. Other per AR SOP 100674766.
- Responsible for communicating business related issues or opportunities to next management level.
EXPERIENCE AND EDUCATION:
- Degree in science with a minimum of 2 years of experience within a QA or RA environment in pharmaceutical industry.
- Working knowledge of the European Regulation and laws as it pertains to Medical Devices.
- Practical knowledge of ISO13485.
- Experience in the Medical Device industry or medical field Demonstrated knowledge of manufacturing principles and practices, and procedures.
- Ability to define problems, gather information, plan and execute objectives.
- Demonstrate project management skills with strong results orientation.
- Teamwork skills.
- Strong communication, influence and presentation skills.
- Fluent in English (required) and in another European language (e.g. French, Dutch, German).
Note: This is a contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Ausy. Ausy can offer you a contract of indefinite duration, a project contract for the duration of the assignment at J&J or a freelance contract.