Regulatory Affairs Manager (m/f/d)
To support our Applications team in Hamburg, we are looking for a highly motivated and committed Regulatory Affairs Manager (m/f/d)
- Development of approval strategies and procedures in accordance with national and international legal requirements and guidelines
- Preparation of documents and dossiers for international approvals and registrations
- Consulting of internal departments to ensure compliance with regulatory requirements
- Support in the creation and maintenance of technical documentation
- Review and evaluation of data and documents regarding their suitability for approval purposes
- Communication with regulatory authorities
- Support of our subsidiaries and sales partners with regional product approvals
- Successfully completed scientific studies or comparable qualification
- Initial professional experience in the field of regulatory affairs for medical devices, ideally in the field of in vitro diagnostics
- Knowledge of European and non-European regulations and standards relevant to certification in particular EN ISO 13485, EN ISO 14971, EN 62366-1, IVD Directive 98/79/EC, REGULATION (EU) 2017/746 (IVDR)
- Excellent communication skills in German and English (written and spoken)
- Sound knowledge of MS Office
- Strong communication and teamwork skills
- Careful, reliable, and solution oriented working style
Benefit from a wide range of opportunities available within an expanding international company. You will work both independently and as part of a team in a highly motivated, open, and friendly environment. Family-friendly working hours along with a pleasant and familial working atmosphere await you.
Are you interested?
Then we are looking forward to receiving your detailed application including your availability and salary expectations. Please send us your complete application documents (ideally in PDF format) using the “Apply now” button. Your contact person is Ms. Dina Jensen.