Regulatory Affairs Specialist (m/f/d)
About the Role
We are seeking a Regulatory Affairs Specialist to support regulatory compliance and market access for life science products. This role involves managing regulatory processes, preparing documentation, and ensuring adherence to applicable regional and international regulations.
Key Responsibilities
- Prepare and maintain regulatory documentation and technical files
- Ensure compliance with applicable regulations and standards (e.g., EU, FDA, ISO)
- Lead and support product registrations, submissions, and approvals
- Monitor regulatory changes and assess impact on products
- Collaborate with cross-functional teams including R&D, Quality, and Manufacturing
- Support audits, inspections, and authority interactions
Qualifications
- Degree in Life Sciences, Biotechnology, Chemistry, or related field
- Proven experience in regulatory affairs within the life sciences, biotech, or medical device industry
- Demonstrated track record of successful regulatory approvals for relevant products
- Knowledge of global regulatory frameworks and quality standards
- Native or fluent German and good working proficiency in English
- Strong organizational skills and attention to detail
- Effective communication and stakeholder management abilities
Preferred
- Experience with international product registrations
- Familiarity with ISO standards (e.g., ISO 13485)
- Understanding of biological or pharmaceutical products