Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
About the role
- Regulatory Affairs Manager overseeing medical device registrations and compliance for AVIA Pharma's products. Collaborating with internal teams and external authorities to ensure regulatory adherence in healthcare.
Responsibilities
- Responsible for the approval and registration of our medical devices (Class I/IIa under the 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 identification and implementation of necessary actions
- Support during audits and inspections and assistance to Quality Management
Requirements
- Degree in Pharmacy, Chemistry, Biology, Medical Engineering, Food Chemistry or a related field
- Professional experience in Regulatory Affairs, ideally with a focus on medical devices
- Knowledge of dietary supplements and cosmetics is an advantage
- Strong knowledge of relevant EU regulations/standards
- Experience in liaising with authorities/Notified Bodies
- Excellent spoken and written German and English
Benefits
- Coffee, tea & water – unlimited during working hours
- Team events – we promote team spirit because we are stronger together
- Option to work in a mobile office (remote/hybrid work option)
- Birthday gift – because everyone is special
- Company pension scheme – thinking of tomorrow today
- Subsidy for computer glasses – so everything is clear and easy to read
- E-bike/bike leasing – cycle to work
- eGym Wellpass – promoting your well-being
- Special leave – for various occasions such as birth, marriage, bereavement
- 30 days of annual leave per year
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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