Quality & Regulatory Affairs Manager - Medical Devices (Remote)

About the Role

We are seeking a Quality & Regulatory Affairs Manager to join our team in a remote capacity. In this role, you will be responsible for the continuous development of our Quality Management System (QMS) for medical devices. As a Quality & Regulatory Affairs Manager, you will ensure compliance with legal and normative regulations, including MDR, FDA, and ISO 13485.

What You'll Do

• Develop and maintain the Quality Management System (QMS) and Quality Management Handbook (QMH).
• Create, review, and train Standard Operating Procedures (SOPs) while adhering to regulatory requirements.
• Design and oversee the conformity assessment process in accordance with MDR, FDA, and ISO 13485.
• Prepare, conduct, and follow up on internal and external audits.
• Participate in product development projects and support technical departments with regulatory inquiries.
• Manage service providers, particularly testing laboratories and medical writers.

Requirements

• Experience in Quality Management or Regulatory Affairs within the medical technology sector or a similar environment.
• Understanding of the principles and requirements of MDR and ISO 13485.
• A degree in engineering, life sciences, or a related technical field, or equivalent practical experience.
• Strong communication and problem-solving skills.
• Fluency in English and German, both written and spoken.
• Willingness to learn and adapt as needed.

Nice to Have

• Experience with international regulatory submissions.
• Knowledge of risk management processes.
• Familiarity with project management methodologies.

What We Offer

• Competitive salary and benefits package.
• Pluxee Benefit Card for employee perks.
• Employee parking and meal subsidies.
• JobRad bike leasing program.
• Continuing education opportunities.
• Company pension scheme.
• Employee events and team-building activities.