Quality & Regulatory Affairs Manager (m/f/d)

In this role, you will help ensure that our medical device products and quality processes meet applicable regulatory requirements and international standards. Working closely with colleagues across product development and the wider organization, you will provide quality and regulatory expertise throughout the product lifecycle and contribute to the continued effectiveness of our Quality Management System (QMS) In this role, you will:

• Ensure compliance with applicable regulatory requirements, standards and internal processes, translating requirements into effective ways of working.
• Establish, maintain and continuously improve the Quality Management System and related processes in line with international regulatory requirements and standards.
• Provide quality assurance expertise to support product design and development activities.
• Participate in product and process risk assessments.
• Review product design documentation from a quality and regulatory perspective.
• Review and approve Corrective and Preventive Actions (CAPAs) and complaint-related activities to support compliance.
• Promote awareness and understanding of quality system and regulatory requirements across the organization.
• Support appropriate product licensing and compliance with legal and standards requirements in target medical device markets.
• Conduct internal audits and coordinate or host external audits.
• Maintain the company's library of relevant regulatory and standards resources.

Essential

• A Master’s degree in a relevant scientific or technical field with at least 2 years of relevant experience, or a Bachelor’s degree in a relevant technical field with at least 4 years of relevant experience.
• At least 3 years of experience working in a regulated medical device environment.
• Practical knowledge of EU and US medical device regulations, including the EU Medical Device Regulation (MDR) and 21 CFR Part 820.
• Knowledge of relevant ISO and IEC standards, such as ISO 13485, ISO 14971, IEC 62304 and IEC 62366-1.
• Experience conducting audits.
• Strong written and spoken English, including the ability to communicate regulatory information clearly and accurately.

Nice to have

• Knowledge of regulatory requirements relating to AI-enabled software.
• Experience leading internal audits.

We offer

We have short decision-making processes and a friendly, competent, diverse team of computer scientists, physicists and dental technicians. You have the flexibility to work as you like between our modern offices in Chemnitz, and remotely from home (hybrid).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.