Quality & Regulatory Affairs Systems Associate
Job Description
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 Quality & Regulatory Affairs Systems Associate, you will support regulatory filings and product registrations required to market Zimmer Biomet products in EMEA.
You will 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 You'll 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
- Strong writing, communication, and problem-solving skills.
- High attention to detail, organizational skills, and ability to multi-task and prioritize.
- Solid understanding of regulatory pathways for medical devices, biologics, and combination products.
- Ability to work independently, under pressure, and in cross-functional teams.
- Basic knowledge of MDR/FDA regulations and international regulatory requirements preferred.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint); SAP experience preferred.
- Ability to stay current with evolving regulatory and quality standards.
Your Background
- Bachelor’s degree in Life Sciences, Engineering, Business, Political Science, or related field.
- First experience in regulatory affairs, quality assurance, or related registration activities preferred.
- Experience with dossier preparation preferred.
- A combination of education and experience may be considered.
Travel Expectations
Up to 15%.
EOE/M/F/Vet/Disability