QA/RA Specialist

Complaint Handling

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.

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.

What You Can Expect

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.

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).

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).

Compensation
The 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.

Applicable CCNL: National Collective Labour Agreement for employees of companies in the Tertiary, Distribution and Services sectors – CNEL code H011

Minimum annual salary: 32,299.00 €

Variable 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.

Principal Duties And Responsibilities

Quality Management System (QMS) support

Regulatory Compliance

Complaint Handling

Field Actions (Recalls)

Audits internal/ external

How You'll Create Impact
Detailed tasks

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.

Ensure awareness about QMS across the local organization Zimmer Biomet LRD.

Drive CAPAs and Issue Evaluations as per the internal procedures.

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.

Support his/her team and QA/RA EMEA with QA/RA standardization of processes.

Work on continuous improvement of processes where applicable and needed.

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.

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.

Support the QA/RA Manager and other colleagues in the QA/RA team as needed.

Regulatory Compliance

Be responsible for product registration, notifications, renewals, and/or regulatory clearance in the assigned market in accordance with local regulatory requirements.

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.

Represent Zimmer Biomet in a local medical device trade association where applicable.

Follow internal Zimmer Biomet procedures and processes for regulatory activities, including GRP, RIMS, GTS, FN, CLARITAS, and related systems.

Provide regulatory support to com