Quality & Regulatory Affairs Specialist

As part of the EMEA Quality Commercial & Distribution Team within the Commercial Organization, you will be responsible for supporting the Quality Assurance & Regulatory Affairs function of Benelux, Nordics, Germany, Austria.

You will ensure compliance with the requirements of ISO 13485 Quality Management System, appropriate company policies and any other ISO if applicable or required in country (i.e ISO9001, ISO14001, ISO37001 e.t.c).

In addition you will ensure that local organization comply with industry specifications, standards and European as also in country regulations (i.e European Medical Device Regulation (EU) 2017/745).

Quality Management System (QMS) Implementation

• Support implementation, development, maintenance, and improvement of the local QMS (Quality Management System)
• Drive CAPAs and Issue Evaluations as per the internal procedures
• Participate, provide support and manage the Management Review Meetings, Risk Management Reviews, Supplier Review Boards, Distributor Review Board, CAPA Review Board meetings and other QMS relevant
• Support his/her team and QA/RA EMEA with QA/RA standardization of processes

Regulatory Compliance

• Be responsible for product registration, notifications, or renewals and/or regulatory clearance in assigned market
• Be main contact for the local competent authority, where applicable, and responsibility for the maintenance of the business in the local market and distributors markets in assigned region. Act as a local regulatory responsible person, if required by local in-country law
• Follow internal Zimmer Biomet procedures and processes for Regulatory activities like GRP, RIMS, GTS, FN, CLARITAS etc.
• Provide regulatory support to commercial and in-country local commercial teams, including support for tenders or delivery of regulatory documents for reimbursement or other commercial activities
• Manage and maintain regulatory documentation, ensuring it complies with applicable regulatory standards and guidelines

Complaint Handling

• Be responsible for complaint handling (submission, coordination of product return, follow-up investigation)
• Share with the management the KPIs related to Complaints

Field Actions (Recalls)

• FSCA initiation: Liaison between FSCA team and regional stakeholders to initiate recalls in impacted country immediately after being received.
• Handling the Field Safety Notices to the affected customers and accountable for reporting the reconciliation of products and customers acknowledgment to the PMS team or FSCA Team
• Be responsible for the handling of instructed actions like Field Notices (FN), Product Holds
• Share with the management the KPIs related to FSCA

Audits internal/ external

• Plan, support and join the internal and external audits in assigned region

• B.S. or M.S. degree in biomedical/clinical engineering, pharma, biological or medical science or equivalent experience required.
• 2+ years’ experience in registration/notification activities and/or quality assurance in medical devices, pharma, or veterinary area.
• English language is a basic requirement, high standard of English speaking-writing skills.
• Not essential, but a plus: Knowledge of ISO standards (ISO13485, ISO9001), and other relevant regulatory requirements. Knowledge of European Medical Device Regulations (i.e EUMDR 2017/745) and local applicable regulations. Knowledge of regional/in-country Medical Device legislation.
• Experience with Windows Office Software, especially Excel and Power Point, SAP.