Quality Management / Regulatory Affairs Specialist - 50-80% (M/F/D)

Quality Management / Regulatory Affairs Specialist - 50-80% (m/f/d)

Are you ready to lead innovation and make a meaningful difference in the world of healthcare technology? At Symphera, we’re transforming patient care with groundbreaking surgical instruments. Based in Munich, Germany, our dynamic MedTech startup is passionate about innovation and inclusivity, and we’re excited to welcome a new member to our growing team.

Your Role

As a valued contributor to our team, you will:

• Build and maintain the QMS in compliance with ISO 13485, ensuring efficient and compliant processes throughout the organization.
• Lead internal and external audits as the primary liaison for authorities and notified bodies, ensuring audit readiness and regulatory excellence.
• Oversee and integrate risk management processes into product development and lifecycle workflows in alignment with industry standards.
• Ensure adherence to EU MDR, FDA regulations, and key standards such as IEC 60601 and IEC 61010.
• Collaborate with internal teams and external consultants to align QMS and regulatory processes across all organizational levels.
• Train and mentor teams, promoting quality and regulatory best practices to foster a culture of compliance and continuous improvement.

Your profile

• A minimum of 5 years of experience in medical device manufacturing or consultancy.
• Expertise in certifying Class II medical devices and mechatronic surgical systems, with a proven track record of bringing medical instruments to market in compliance with FDA and MDR requirements.
• Proficient knowledge of regulatory frameworks, including FDA regulations, EU MDR, and relevant standards.
• A Bachelor or Master degree in engineering or a related field.
• Strong communication and collaboration skills, enabling you to thrive in a diverse and dynamic team environment.
• Enthusiasm for learning and contributing in a fast-paced startup, where your efforts directly influence outcomes and success.

Why you should join us

• Innovative Impact: Be part of a company that is improving lives. Our work transforms surgical technology, making procedures safer, more precise, and patient-focused.
• Empowering Culture: At Symphera, we embrace diversity and value your unique perspective. Collaboration, curiosity, and shared purpose drive everything we do.
• Supportive Team: Work alongside a talented, inclusive, and supportive team where your ideas matter, and your contributions make a real difference.
• Flexibility for You: We understand the importance of balance. Our hybrid working model allows you to thrive professionally while prioritizing your personal life.
• Room to Grow: As a fast-growing startup, we offer opportunities for professional development and career growth.
• Meaningful Work: Your efforts will have a tangible impact on improving patient outcomes and shaping the future of healthcare.

Join Us in Making a Difference

At Symphera, we believe innovation starts with diverse perspectives and a supportive environment. If you’re passionate about shaping the future of healthcare, we want to hear from you!

Symphera is an equal opportunity employer, and we are committed to fostering an inclusive environment where everyone can thrive.

Art der Stelle: Teilzeit

Leistungen:

• Erfolgsbeteiligung
• Flexible Arbeitszeiten
• Gleitzeit
• Homeoffice-Möglichkeit

Berufserfahrung:

• Regulatory Affairs and Quality Management: 3 Jahre (Erforderlich)

Arbeitsort: Zum Teil im Homeoffice in 80992 München