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)

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

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