Quality Assurance & Regulatory Affairs Specialist

<p>At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.  </p><p>As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards.  We are committed to creating an environment where every team member feels included, respected, empowered and recognised.</p><br><div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>What You Can Expect</H2> </div><div><ul><li>The QARA Specialist, as part of the EMEA Quality Commercial & Distribution Team within the Commercial Organization, will be responsible for supporting the Quality Assurance & Regulatory Affairs function of the assigned region.</li><li>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).</li><li>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).</li></ul><p> </p><p><strong>Principal Duties and Responsibilities:</strong></p><p> </p><ul><li>Quality Management System (QMS) support</li><li>Regulatory Compliance</li><li>Complaint Handling</li><li>Field Actions (Recalls)</li><li>Audits internal/ external</li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>How You'll Create Impact</H2> </div><div><h5>Detailed tasks</h5><h5>Quality Management System (QMS)</h5><ul><li>Support implementation, development, maintenance, and improvement of the local QMS (Quality Management System), according to international standards and corporate guidelines, policies, and procedures, as per instructions of the direct manager.</li><li>Ensure awareness about QMS across the local organization Zimmer Biomet LRD.</li><li>Drive CAPAs and Issue Evaluations as per the internal procedures.</li><li>Participate in, provide support for, and manage Management Review Meetings, Risk Management Reviews, Supplier Review Boards, Distributor Review Boards, CAPA Review Board meetings, and other QMS-related activities, if applicable to the assigned region.</li><li>Support his/her team and QA/RA EMEA with QA/RA standardization of processes.</li><li>Work on continuous improvement of processes where applicable and needed.</li><li>Ensure continuous communication, reporting, and escalation to the QA/RA manager or supervisor and QA/RA EMEA as needed and according to the instructions of the direct manager.</li><li>Become involved in special projects and duties at the country or EMEA level, such as (re-)validation of technical systems and procedures, implementation of new tools, and similar activities, as assigned by the direct manager.</li><li>Support the QA/RA Manager and other colleagues in the QA/RA team as needed.</li></ul><h5>Regulatory Compliance</h5><ul><li>Be responsible for product registration, notifications, renewals, and/or regulatory clearance in the assigned market in accordance with local regulatory requirements.</li><li>Be the main contact for the local competent authority where applicable, and be responsible for maintaining the business in the local market and distributor markets within the assigned region. Act as a local regulatory responsible person if required by local law.</li><li>Represent Zimmer Biomet in a local medical device trade association where applicable.</li><li>Follow internal Zimmer Biomet procedures and processes for regulatory activities, including GRP, RIMS, GTS, FN, CLARITAS, and related systems.</li><li>Provide regulatory support to commercial and local in-country teams, including support for tenders and provision of regulatory documents for reimbursement or other commercial activities.</li><li>Manage and maintain regulatory documentation, ensuring compliance with applicable regulatory standards and guidelines.</li><li>Ensure awareness of regulatory activities and processes across the market and country.</li><li>Assist with effective, consistent, and reliable Product Surveillance by forwarding information concerning changes and/or new local regulatory requirements, European regulations such as MDR, or Zimmer Biomet procedures to ensure business continuity, as instructed by the direct manager.</li></ul><h5>Complaint Handling</h5><ul><li>Be responsible for complaint handling, including submission, coordination of product returns, and follow-up investigations.</li><li>Share complaint-related KPIs with management.</li></ul><h5>Field Actions (Recalls)</h5><ul><li>Act as liaison between the FSCA team and regional stakeholders to initiate recalls in impacted countries immediately upon receipt of notification.</li><li>Manage Field Safety Notices for affected customers and be accountable for reporting product reconciliation and customer acknowledgements to the PMS team or FSCA team.</li><li>Be responsible for handling instructed actions such as Field Notices (FN) and Product Holds.</li><li>Share FSCA-related KPIs with management.</li></ul><h5>Audits (Internal and External)</h5><ul><li>Plan, support, and participate in internal and external audits within the assigned region as appropriate.</li><li>Ensure audit preparation activities are completed and provide support to auditees.</li><li>Ensure appropriate follow-up on Internal, EMEA, and External Audits as required by internal procedures.</li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>What Makes You Stand Out</H2> </div><div><h5>Expected areas of Competence:</h5><p>•    Organized: Ability to handle high volume of correspondence and prioritize work accordingly<br />•    Autonomous: Ability to work independently and collaboratively in a team-oriented environment.<br />•    Methodical: Ability to prepare high quality, clear communication materials to the appropriate audience<br />•    Excellent communication and interpersonal skills.<br />•    Detail-oriented: with a commitment to accuracy and precision.<br />•    Diplomatic and tenacious. <br />•    Discretion and confidentiality<br />•    Fluent in English<br />•    Ability to work in a multinational team.<br />•    Ability to adapt to changing environment.</p></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Your Background</H2> </div><div><h5>Education/Experience requirements:</h5><p>•    B.S. or M.S. degree in biomedical/clinical engineering, pharma, biological or medical science or equivalent experience required.<br />•    3+ years’ experience in registration/notification activities and/or quality assurance in medical devices, pharma, or veterinary area.<br />•    English language is a basic requirement, high standard of English speaking-writing skills.<br />•    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.<br />•    Experience with Windows Office Software, especially Excel and Power Point, SAP.</p><p> </p><p><strong>If this sounds like you, we invite you to apply submitting your CV in English.</strong></p></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Physical Requirements</H2> </div><div></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Travel Expectations</H2> </div><div><p>5%</p></div></div></div><br><p>EOE/M/F/Vet/Disability</p>