AVIA Pharma Germany

Regulatory Affairs Manager

AVIA Pharma Germany

full-time

Posted on:

Location Type: Hybrid

Location: Wolfratshausen • Germany

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About the role

  • Responsible for the approval and registration of our medical devices (Class I/IIa under the MDR);
  • Support with dietary 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 cooperation 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
  • Coffee, tea & water – unlimited during working hours;
  • Team events – designed to promote our team spirit, because we are stronger together;
  • Option to work in a mobile/home office;
  • Birthday gift – because we’re all special;
  • Company pension scheme – thinking about tomorrow today;
  • Subsidy for computer/office glasses – to keep everything clear and sharp;
  • E‑bike/bike leasing – cycle to work;
  • eGym Wellpass – when you feel good, we do too;
  • Special leave – for various occasions such as birth, wedding, 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 & Tools
regulatory affairstechnical documentationcomplianceauditsinspectionsmedical devicesdietary supplementscosmeticsEU regulationsquality management
Soft Skills
communicationcooperationmonitoringassistance
Certifications
degree in Pharmacydegree in Chemistrydegree in Biologydegree in Medical Engineeringdegree in Food Chemistry