Consultant Medical Devices Quality & Regulatory Affairs

What you’ll do

Qserve offers an exciting opportunity to join our team as a Consultant Medical Devices Quality & Regulatory Affairs. In this role, you will support a wide variety of clients in the medical device industry. Leveraging your regulatory expertise, you will help Qserve’s clients achieve their business goals by providing hands-on support, ensuring regulatory compliance, and enabling market access for a broad range of medical devices. You will be part of a global team of medical device experts, working collaboratively across regions and time zones to deliver high-quality support to our clients.

What you’ll bring to the team

We are looking for a highly motivated and passionate Quality and Regulatory professional with experience in writing and reviewing technical documentation for medical devices, as well as auditing expertise. With your strong understanding of design and development processes (specifications, verification, and validation) and risk management, you are able to work with a wide variety of medical device technologies and guide clients toward successful global compliance. In this role, you thrive on variety and are able to manage multiple projects simultaneously. You enjoy teaching and coaching and can effectively communicate regulatory topics to both technical and non-technical stakeholders. As we are a service-oriented organization, you take satisfaction in supporting others. You also enjoy writing technical and regulatory documentation.

Your profile:

• Technical or scientific degree (BSc, MSc, or PhD) in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology, or a related field.

• At least 3 - 5 years of professional experience in the medical device field (EU MDD and EU MDR), gained in industry, consultancy, or a Notified Body, in quality, regulatory, or clinical roles (e.g., Regulatory Affairs Specialist or Quality and Regulatory Manager).

• Solid knowledge of quality assurance and regulatory affairs within the MedTech industry or a Notified Body environment.

• Qualified to perform ISO 13485 and MDSAP audits as a lead auditor.

• In-depth knowledge of EU Medical Device Regulations (EU MDR) and US regulations.

• Familiarity with medical device risk management.

• Hands-on experience in writing technical and regulatory documentation.

• Experience in implementing and managing medical device quality management systems (ISO 13485).

• Practical knowledge of project management.

• Pragmatic mindset, enjoying a mix of regulatory affairs and quality assurance activities.

• Strong communication skills and a service-oriented attitude.

• Excellent organizational skills and attention to detail, with the ability to manage multiple projects simultaneously.

• Fluent in English and German.

• Valid driver’s license.

• Based in Germany.