Quality Management & Regulatory Affairs Manager – Medical Devices (m/f/d)

Avia Pharma Germany (neubourg group & Allergika Group); München; Hybrid; EUR 75,000 - 110,000; Full time

Benefits offered by this job

Hybrid working

30 days vacation

Company pension

Wellness program

Birthday gift

Fruit & drinks

Job summary

Avia Pharma Germany is seeking a Quality Management & Regulatory Affairs Manager to ensure our medical device portfolio meets high quality and regulatory standards. You will manage QM processes across Avia Pharma Germany, remain audit-ready per ISO 13485 and MDR, and report to the Director of Scientific Affairs DACH.

Hybrid work option and full-time position in Wolfratshausen near Munich. Your responsibilities include change control, CAPA, audits, QMS maintenance, regulatory support, and

Qualifications

• University degree in a relevant scientific, technical, medical or pharmaceutical discipline.
• At least 1 year of regulatory affairs experience for medical devices.
• At least 1 year of quality management experience for medical devices (CAPA, change & complaint handling).
• Sound knowledge of ISO 13485 and MDR.
• Desirable: audit experience and auditor qualification; experience with eQMS systems and RA databases.
• Advantage: background in dermatology, medicinal products, cosmetics or food supplements.
• Business-fluent German and English, both written and spoken.

Responsibilities

• Operational management of change control, complaint handling and CAPA for Avia Pharma Germany.
• Preparation and execution of internal audits and ensuring audit readiness in line with ISO 13485 and MDR.
• Maintenance and development of the quality management system, including migration to an eQMS.
• Regulatory support for the medical device portfolio.
• Maintenance and updating of technical documentation.
• Support with ongoing vigilance activities.

Skills

Regulatory affairs

CAPA

Change control

Audit readiness

Documentation

German & English (biling.)

Attention to detail

Independent working style

Education

University degree in a relevant scientific/technical/medical/pharmaceutical field

Tools

eQMS systems

RA databases

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.

• 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