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RA Systems Associate
  • Warsaw
RA Systems Associate
Warszawa, Warsaw, Masovian Voivodeship, Polska
Zimmer Biomet
16. 12. 2025
Informacje o stanowisku

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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

As a RA System Associate you are part of the Regulatory Affairs (RA) team for the EMEA Region to support regulatory filings and product registrations required to market Zimmer Biomet products in EMEA. You ensure timely submissions, maintain regulatory compliance, support product surveillance activities, and act as a liaison with regulatory authorities. This is an entry-level position, developing full competency in Quality and Regulatory Affairs (QARA).

How Youll Create Impact

  • Prepare and support regulatory filings (GRP creations, local submissions) to ensure timely product registrations and approvals.
  • Maintain and update product registrations in accordance with local legal requirements; act as main contact with competent authorities where applicable.
  • Monitor and communicate changes in global/local regulatory requirements; ensure compliance and continuity of business operations.
  • Review and approve local labeling, promotional materials, and package inserts for compliance with applicable regulations in the countries.
  • Support the implementation, maintenance, and improvement of quality management systems (QMS) aligned with international standards and corporate policies.
  • Participate in internal and external audits, including serving as an internal auditor if needed; assist in audit preparation and corrective actions.
  • Support special projects such as procedure updates or cross‑functional initiatives.

What Makes You Stand Out

You demonstrate strong writing, communication, and problem‑solving abilities. In addition you have a high attention to detail, strong organizational skills, and the ability to multi‑task and prioritize effectively.

You possess a solid understanding of regulatory pathways for medical devices, biologics, and combination products. You are able to work independently and under pressure, while also thriving in cross‑functional team environments.

Ideally you have foundational knowledge of MDR/FDA regulations and international regulatory requirements. You are proficient in Microsoft Office Suite, including Word, Excel, and PowerPoint, and have experience with SAP.

Your Background

You hold a Bachelor’s degree in Life Sciences, Engineering, Business, Political Science, or in a related field, combined with up to 3 years of experience in regulatory affairs, quality assurance, or related registration activities.

A First Experience With Dossier Preparation Is Preferred.

  • Seniority level: Entry level
  • Employment type: Full‑time
  • Job function: Information Technology
  • Industries: Medical Equipment Manufacturing

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