Informacje o stanowisku

For our client—an international company based in Wrocław, with a rapidly expanding EMEA Regulatory Affairs team—were looking for a highly experienced and self-driven Regulatory Affairs Specialist/Senior Specialist to join their dynamic global team. If youre passionate about ensuring product compliance and have a deep understanding of medical device regulations, we want to meet you!

What we expect

• A minimum of 5 years of hands-on experience as a Regulatory Specialist within the Medical Device industry.
• A Masters degree or PhD in a relevant field such as Life Science, Bioscience (Biology, Engineering, Biotechnology, etc.)
• Excellent understanding and demonstrated knowledge of the EU Medical Device Regulation (MDR) - previously EU Medical Devices Directive (MDD).
• Familiarity with other relevant regulations like CPR (Construction Products Regulation) and BRP (Basic Requirements for Packaging) is a plus.
• Proven ability to work independently, demonstrating deep knowledge and skills in regulatory affairs.Strong analytical skills and attention to detail, with a focus on compliance and regulatory interpretation.
• Any relevant certifications are a nice-to-have.

Agencja zatrudnienia – nr wpisu 47

ta oferta pracy przeznaczona jest dla osób powyżej 18 roku życia

What we offer

• Fully remote working model
• Quick start date
• Flexible working hours - 8:00/9:00 - 16:00/17:00
• Private medical care (individual and family packages)
• Group insurance (in PZU)
• Sports card - MultiSport (for you and your loved ones)
• Online cafeteria - benefit platform (discounts e.g. for cinema tickets)

Your tasks

• Independently manage and execute medical device registration processes.
• Lead all major Regulatory Affairs activities.
• Interpret and implement relevant regulations, ensuring products comply with all necessary standards.
• Take control over changes in product data and specifications, utilizing Product Lifecycle Management (PLM) systems.
• Collaborate with both our 5-person EMEA team and the broader 35-person global team to support global regulatory processes.
• Work with Technical Documentation, Declarations of Conformity (DoC), General Safety and Performance Requirements (GSPR), and all other necessary regulatory documentation in accordance with EU MDR requirements, ensuring their proper approval in the Product Lifecycle Management (PLM) system.
• Engage in extensive collaboration with internal functional teams (Quality, Operations, R&D) and external parties (Suppliers, Distributors).
• Conduct thorough reviews of Labeling and Promotional materials for compliance with MDR, CPR, BRP, and specific Member State requirements.
• Identify, initiate, plan, recommend, promote, and implement broad Regulatory Affairs programs and projects at the Division and Regional levels.
• Independently identify required plans, business justifications, resources, schedules, and interactions to achieve complex regulatory objectives.

Wrocław - Oferty pracy w okolicznych lokalizacjach