Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Szczecin we have our Business Centre that works with global financial operations, orders administration, HR and IT support, Legal & Business Ethics, marketing & data analysis activities, and many others. If you have the right profile and the right amount of curiosity and ambition you can be a part of this exciting challenge. Curiosity works here!
The team is located in Coloplast Business Centre in Szczecin, Poland and are looking for a Senior Regulatory Affairs Specialist. Regulatory Affairs team is part of the Global Regulatory Affairs department of Coloplast, which comprises over 70 colleagues from around the world. The team is involved in the development of regulatory strategies and registration of medical devices in various countries around the world. In this role, you will be involved in building regulatory intelligence across the organization and ensure successful devices global launches across different business areas.
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.
- 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
Your personal skills
- Analytical, systematic and solution-oriented way of working
- Strong commitment, initiative and sense of duty
- Holistic thinking and an open-minded attitude
- Experience of working in an international environment
