Quality Management & Regulatory Affairs Manager – Medical Devices (m/f/d)
Company: Avia Pharma Germany (neubourg group & Allergika Group)
- Location: Munich, Germany
- Work mode: Hybrid
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
As Quality Management & Regulatory Affairs Manager (m/f/d), you ensure that our medical device portfolio meets the highest quality and regulatory standards. You are responsible for key QM processes for the companies of Avia Pharma Germany, keep us audit-ready at all times in line with ISO 13485 and MDR, and report directly to the Director of Scientific Affairs DACH. Your place of work is Wolfratshausen near Munich, full-time with the option to work remotely.
Your Responsibilities
- Operational management of change control, complaint handling and CAPA for the companies of Avia Pharma Germany
- Preparation and execution of internal audits and ensuring continuous audit readiness in line with ISO 13485 and MDR
- Maintenance and further development of the quality management system, including support for the migration to an eQMS
- Qualified regulatory support for our medical device portfolio
- Contribution to the maintenance and updating of technical documentation
- Support with ongoing vigilance activities
Your Profile
- University degree in a relevant scientific, technical, medical or pharmaceutical discipline
- At least one year of professional experience in regulatory affairs for medical devices
- At least one year of professional experience in quality management for medical devices, including experience in CAPA, change and complaint management
- Sound working knowledge of ISO 13485 and MDR
- Desirable: audit experience (internal/external), ideally with an auditor qualification, as well as experience with eQMS systems and RA databases
- An advantage: background in dermatology, medicinal products, cosmetics or food supplements
- Strong quality mindset, great attention to detail and an independent, structured way of working
- Reliability and assertiveness toward internal and external interfaces, as well as the willingness to take on broader regulatory responsibility over time
- Business-fluent German and English, both written and spoken
Our Promise
We offer you a responsible role in a dynamic working environment with challenging tasks and plenty of room for your own initiative, including the freedom to explore new paths. Short decision-making processes and flat hierarchies help us implement exciting ideas quickly and without red tape.
On top of that, you can look forward to:
- First-name culture: We treat each other as equals – from apprentices to management
- Flexibility: Flexible working hours and a hybrid working model
- Fit & Active: eGym Wellpass membership and (e-)bike leasing
- Time off: 30 days of vacation per year
- Securing your future: Company pension scheme included
- Team spirit: Regular team events
- Little things that matter: Birthday gift, subsidy for computer glasses, plus fruit & drinks
Would you like to help shape our success story? Then we look forward to receiving your meaningful application, including your salary expectations.
