Senior Regulatory Affairs Specialist

Coloplast

Szczecin, Poland

The job

In this position, communicating and collaborating play a key role as you will be the ‘go-to’ person when it comes to regulatory matters involving your products and projects. We are looking for a new colleague who enjoys collaborating across functions and cultures.

Key activities

Craft country-specific regulatory strategies and provide registration files and submissions/filing for new product introductions, maintenance of regulatory approvals and product changes for the assigned geographies, either directly or by coordinating with in-country regulatory affiliates who interact with local regulatory authorities;
Act as regulatory liaison for assigned geographies by ensuring that local regulatory requirements, pathways and registration needs are anchored in global regulatory strategies and executed at a local level, through transparent and clear communication and focus on collaborative work and solution;
Assess acceptability of proposed labeling and technical/clinical documentation to fulfill local regulatory registration needs, in collaboration with global and local counterparts;
Assess transferability of global product claims per local requirements, and review advertising materials for regulatory compliance;
Assist with import/export and trade compliance activities, good sales practices and requests supporting commercial activities;
Support post-market surveillance activities;
Report information into applicable data management systems and maintain internal/external regulatory databases;
Monitor and analyze emerging regulatory intelligence for the assigned geographies;
Participate in development, maintenance and implementation of regulatory procedures, instructions and systems.

Your experience/qualification

Bachelor or Master of Science degree in regulatory science, life science, biomedical engineering, or other relevant scientific or legal field;
Minimum 5+ years’ experience in regulatory affairs – preferably from the MedTech industry or a related field;
In depth knowledge of regulatory legislation, standards, and guidelines for medical devices, in particular MDR, MDSAP, EN ISO 13485;
Fluent in English;
Very good MS Office skills.