QA/RA Specialist

pAt 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 pAs 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 h3What You Can Expect /h3 ul liThe 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 liEnsure 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 liEnsure 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 h3Compensation /h3 pThe compensation indicated in this job posting represents the minimum annual salary for the position. Final remuneration will be determined based on the selected candidate’s experience, skills, and qualifications, in accordance with applicable EU pay transparency and pay equity requirements. /p pApplicable CCNL: National Collective Labour Agreement for employees of companies in the Tertiary, Distribution and Services sectors – CNEL code H011 /p pMinimum annual salary: 32,299.00 € /p pVariable Pay: In addition to base salary, the total compensation package may include bonuses, benefits, and other incentives. Your recruiter will discuss these elements with you during the recruitment process. /p h3Principal Duties and Responsibilities /h3 ul liQuality Management System (QMS) support /li liRegulatory Compliance /li liComplaint Handling /li liField Actions (Recalls) /li liAudits internal/ external /li /ul h3How You'll Create Impact /h3 h3Detailed tasks /h3 h3Quality Management System (QMS) /h3 ul liSupport 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 liEnsure awareness about QMS across the local organization Zimmer Biomet LRD. /li liDrive CAPAs and Issue Evaluations as per the internal procedures. /li liParticipate 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 liSupport his/her team and QA/RA EMEA with QA/RA standardization of processes. /li liWork on continuous improvement of processes where applicable and needed. /li liEnsure 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 liBecome 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 liSupport the QA/RA Manager and other colleagues in the QA/RA team as needed. /li /ul h3Regulatory Compliance /h3 ul liBe responsible for product registration, notifications, renewals, and/or regulatory clearance in the assigned market in accordance with local regulatory requirements. /li liBe 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 liRepresent Zimmer Biomet in a local medical device trade association where applicable. /li liFollow internal Zimmer Biomet procedures and processes for regulatory activities, including GRP, RIMS, GTS, FN, CLARITAS, and related systems. /li liProvide 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 liManage and maintain regulatory documentation, ensuring compliance with applicable regulatory standards and guidelines. /li liEnsure awareness of regulatory activities and processes across the market and country. /li liAssist 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 h3Complaint Handling /h3 ul liBe responsible for complaint handling, including submission, coordination of product returns, and follow-up investigations. /li liShare complaint‑related KPIs with management. /li /ul h3Field Actions (Recalls) /h3 ul liAct as liaison between the FSCA team and regional stakeholders to initiate recalls in impacted countries immediately upon receipt of notification. /li liManage Field Safety Notices for affected customers and be accountable for reporting product reconciliation and customer acknowledgements to the PMS team or FSCA team. /li liBe responsible for handling instructed actions such as Field Notices (FN) and Product Holds. /li liShare FSCA-related KPIs with management. /li /ul h3Audits (Internal and External) /h3 ul liPlan, support, and participate in internal and external audits within the assigned region as appropriate. /li liEnsure audit preparation activities are completed and provide support to auditees. /liliEnsure appropriate follow‑up on Internal, EMEA, and External Audits as required by internal procedures. /li /ul h3What Makes You Stand Out /h3 h3Expected areas of Competence /h3 ul liOrganized: Ability to handle high volume of correspondence and prioritize work accordingly /li liAutonomous: Ability to work independently and collaboratively in a team-oriented environment. /li liMethodical: Ability to prepare high quality, clear communication materials to the appropriate audience /li liExcellent communication and interpersonal skills. /li liDetail‑oriented: with a commitment to accuracy and precision. /li liDiplomatic and tenacious. /li liDiscretion and confidentiality /li liFluent in English /li liAbility to work in a multinational team. /li liAbility to adapt to changing environment. /li /ul h3Your Background /h3 h3Education/Experience requirements /h3 ul liB.S. or M.S. degree in biomedical/clinical engineering, pharma, biological or medical science or equivalent experience required. /li li3+ years’ experience in registration/notification activities and/or quality assurance in medical devices, pharma, or veterinary area. /li liEnglish language is a basic requirement, high standard of English speaking-writing skills. /li liNot 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. /li liExperience with Windows Office Software, especially Excel and Power Point, SAP. /li /ul h3Physical Requirements /h3 h3Travel Expectations /h3 p5% /p pEOE/M/F/Vet/Disability /p #J-18808-Ljbffr