Regulatory Policy Specialist developing regulatory case filings and strategies supporting company goals at Xcel Energy. Collaborating with stakeholders and senior management to ensure compliance and effective communication.
About the role
- Regulatory Affairs Manager managing medical product registrations and compliance at AVIA Pharma. Collaborating with departments and authorities to ensure compliance with regulations.
Responsibilities
- Responsible for the approval and registration of our medical devices (Class I/IIa under the MDR) and involvement in food supplements and 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 actions
- Support during audits and inspections and assistance to Quality Management (QM)
Requirements
- Degree in Pharmacy, Chemistry, Biology, Medical Engineering, Food Chemistry or a comparable field
- Professional experience in Regulatory Affairs, ideally with a focus on medical devices
- Knowledge of food supplements and cosmetics is an advantage
- Very good knowledge of relevant EU regulations and standards
- Experience working with authorities and Notified Bodies
- Excellent German and English skills, both written and spoken
Benefits
- Flat hierarchies and open communication to support your development and help us continuously improve our services
- Unlimited coffee, tea & water during work hours
- Company events to promote team spirit
- Option to work in a mobile office/remote setting
- Birthday gift
- Company pension scheme – planning for tomorrow today
- Contribution towards computer/screen-use glasses
- E‑bike/bike leasing – commute by bicycle
- eGym Wellpass (corporate wellness program)
- Special leave for occasions such as childbirth, weddings and bereavement
- 30 days of vacation per year
Job title
Job type
Experience level
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Degree requirement
Location requirements
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