This company is at the forefront of the medical technology industry. They are making a difference across Germany and looking for someone who wants to be apart of making a difference too.
Quality and Regulatory Affairs Manager in Healthcare Technology
Your Responsibilities:
- Review and update regulatory and quality management system (QMS) documents to ensure compliance
- Keep all regulatory documentation up to date with laws, standards, and regulations for QMS and products
- Identify the best regulatory pathways for getting products to market
- Continuously improve QMS processes and encourage best practices
- Manage and maintain QMS documentation
- Provide advice on regulatory and quality matters to other teams
- Plan and conduct training on regulatory standards and compliance
What You Bring:
- At least 2 years of experience in Regulatory Affairs or Quality Management, ideally with medical devices or software
- Experience managing QMS systems under ISO 13485 standards
- Knowledge of MDR 2017/745, EN ISO 13485:2016.
- Experience working with teams like Research & Development to create SOPs and work instructions
- Familiarity with U.S. market regulations is a plus
- Experience with medical device vigilance is a bonus
- Understanding of ISO 14971, EN 62304, and EN 62366 is helpful
- Good communication skills, especially in diverse, international teams
- Fluent in English (spoken and written); German is a plus
Benefits:
- Competitive salary with performance-based growth
- Personalized onboarding experience
- Global team shaping the future of healthcare
- Team events
You must be already based in Germany and happy to relocate to Munich.
Quality and Regulatory Affairs Manager in Healthcare Technology - Fixed Salary up to €90,000- (English Language Needed - German Location a plus) Location - Bavaria
