EU MDR Regulatory Affairs Lead — Remote, Fixed-Term

Physiol; Polska; Hybrid; PLN 180,000 - 300,000; Full time

Job summary

Physiol is seeking a Senior Regulatory Affairs Specialist (Maternity Cover) to lead regulatory activities in support of EU MDR compliance. The role collaborates with Medical Affairs, Regulatory Affairs, R&D, Quality Engineering, and Manufacturing to ensure timely updates to product technical documentation and sustained business continuity.

The successful candidate will review gap assessments, coordinate data for EUDAMED submissions, and work with MDR program leads to align timelines.

Qualifications

• Minimum 5 years of experience in Regulatory Affairs in an FDA or ISO regulated environment.
• Experience in preparing EU MDR product technical documentation.

Responsibilities

• Review gap assessments on Product Technical Files against MDR requirements and evaluate documentation.
• Support data collection for submissions to EUDAMED.
• Coordinate updates to technical documentation with RA, MDR program leads, and design teams.
• Assess regulatory impact and relay MDR information to product RA teams and design teams.
• Identify applicable International standards for MDR compliance.
• Consult MDR project management on regulatory questions or issues.
• Engage with Notified Bodies during product technical file reviews.
• Investigate regulatory obstacles and propose viable solutions.
• Support regulatory review of promotional materials and product labeling related to MDR.
• Assist new product development data collection for MDR submissions and compliance.
• Contribute to ongoing compliance projects.

Skills

Regulatory affairs experience

EU MDR knowledge

Technical documentation

Education

Bachelor's degree in Mechanical, Electrical or Biomedical Engineering or other scientific discipline

Job description

Physiol is seeking a Senior Regulatory Affairs Specialist (Maternity Cover) to lead regulatory activities in support of EU MDR compliance. The role collaborates with Medical Affairs, Regulatory Affairs, R&D, Quality Engineering, and Manufacturing to ensure timely updates to product technical documentation and sustained business continuity.

The successful candidate will review gap assessments, coordinate data for EUDAMED submissions, and work with MDR program leads to align timelines.