Senior Regulatory Affairs Specialist

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

Job Details: Senior Regulatory Affairs Specialist - Maternity Cover

Full details of the job.

Job Requisition Name

Job Requisition Name Senior Regulatory Affairs Specialist - Maternity Cover

Job Requisition No

Job Requisition No VN8505

Work Location Name

Work Location Name Poland - Remote

Worker Basis

Worker Basis Full Time

Worker Type

Worker Type Self-Employed/Contractor

Contract Type

Contract Type Fixed Term

Applications Close Date

Purpose

The Senior Regulatory Affairs Specialist will be responsible for preparing gap assessments and preparing updates to BVI's product technical documentation to meet the requirements of Medical Device Regulation (EU) 2017/745 and support ongoing compliance projects. The incumbent will interface with and assess documents from various departments such as Medical Affairs, Regulatory Affairs, R&D, Quality Engineering and Manufacturing to support EUMDR compliance and ensure business continuity.

Key Responsibilities

• Review and understand gap assessments on Product Technical Files against MDR requirements. Review all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability protocols & reports, manufacturing process information, biocompatibility evaluation of risk reports, list of applicable standards, list of general safety and performance requirements, declaration of conformity, and clinical data.
• Support the collection and provision of data required to submit to EUDAMED.
• Work with regulatory affairs and MDR program work stream leads to ensure technical documentation update timelines are aligned.
• Participate in regulatory impact assessments as it relates to the MDR and relay the information to product specific RA team member and/or design teams.
• Identify use of appropriate International standards.
• Bring MDR Regulatory Affairs questions/issues to the attention of MDR Project Management team.
• Interact with Notified Body reviewers and auditors during product technical file active reviews.
• Determine issues which may create regulatory obstacles; investigate and propose solutions.
• Serve as MDR Regulatory Affairs team member for promotional materials review and product labeling as they relate to MDR registration and commercialization of medical devices.
• Support new product development teams to assure collection of appropriate data for MDR regulatory submissions and compliance.
• Support ongoing compliance projects.
• Adhere to and ensure the compliance of BVIs Code of Ethics, all Company policies, rules, procedures, and standards.

Qualification

• Minimum of a bachelor’s degree in Mechanical, Electrical, Biomedical Engineering or other scientific discipline
• Minimum of 5 years of experience in Regulatory Affairsin an FDA or ISO regulated environment
• Experienced in the preparation of EU MDR product technical documentation.