Regulatory Affairs Manager
AVIA Pharma Germany
full-time
Posted on:
Location Type: Hybrid
Location: Greven • 🇩🇪 Germany
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Responsible for the approval and registration of our medical devices (Class I/IIa under MDR) and participation in dietary supplements/cosmetics
- Preparation, maintenance and review of technical documentation
- Ensuring compliance with all relevant regulatory requirements
- Review and approval of packaging and promotional materials
- Close collaboration with internal departments, external consultants, authorities and notified bodies
- Active monitoring of regulatory developments and implementation of necessary measures
- Support during audits and inspections and assistance to Quality Management (QM)
Requirements
- Degree in Pharmacy, Chemistry, Biology, Medical Engineering, Food Chemistry or a comparable qualification
- Professional experience in Regulatory Affairs, ideally with a focus on medical devices
- Knowledge of dietary supplements and cosmetics is an advantage
- Very good knowledge of relevant EU regulations/standards
- Experience working with authorities and notified bodies
- Very good German and English skills, both written and spoken
Benefits
- Unlimited coffee, tea & water during work
- Company events to foster team spirit — because we are stronger together
- Option to work in a mobile/home office
- Birthday gift — because everyone is special
- Company pension scheme — think of tomorrow today
- Contribution toward glasses for screen work — so everything stays clear
- E‑bike/bike leasing — cycle to work
- eGym Wellpass — when you feel good, we feel good
- Special leave for various occasions such as childbirth, marriage, bereavement
- 30 days of vacation per year
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairstechnical documentationcomplianceauditsinspectionsmedical devicesdietary supplementscosmeticsEU regulationsquality management
Soft skills
collaborationcommunicationmonitoringproblem-solving
Certifications
degree in Pharmacydegree in Chemistrydegree in Biologydegree in Medical Engineeringdegree in Food Chemistry