What you’ll do
Qserve offers an exciting opportunity to join our team as a Consultant Medical Devices Regulatory Affairs. In this role, you will support clients in the medical device industry, with a strong focus on regulatory strategy, compliance, and market access. Leveraging your regulatory expertise, you will guide clients through complex global regulatory frameworks and help bring innovative medical devices to market efficiently and compliantly.
You work closely with clients on a variety of regulatory topics, for example:
Contributing to regulatory strategies for EU MDR and other global markets
Preparing and reviewing technical documentation
Supporting market access activities and regulatory submissions
Advising on regulatory requirements and classification
Keeping up with regulatory developments and helping clients apply them in practice
You’ll collaborate with colleagues and clients across different disciplines and countries, making sure projects move forward and regulatory requirements are met.
What you’ll bring to the team
We are looking for a Regulatory Affairs professional with experience in medical devices and a strong interest in compliance and market access. You enjoy working on a variety of regulatory topics and helping clients navigate requirements across different markets. You take ownership of your work and feel comfortable supporting and advising clients on regulatory matters.
Your profile:
Technical or scientific degree (BSc, MSc, or PhD) in a relevant field (e.g. biomedical engineering, biology, chemistry, physics)
3–5+ years of experience in Regulatory Affairs for medical devices
Hands-on experience with EU MDR, regulatory submissions and technical documentation, and interactions with Notified Bodies or regulatory authorities
Proven experience in writing and reviewing technical documentation, and supporting market access and regulatory strategy
Ability to translate complex regulations into practical, business-oriented solutions
Experience with quality management systems (ISO 13485) is an advantage, not a primary focus
Audit experience (ISO 13485, MDSAP) is nice to have
Strong communication and stakeholder management skills
Ability to manage multiple projects in a dynamic, international environment
Fluent in German and English
Based in Germany
Qserve is a trusted global partner for MedTech Regulatory, Clinical, and Quality Compliance, as well as a full-service CRO for medical device clinical trials.
With a strong international presence in Europe, China, and the United States, our team of experts combines deep regulatory knowledge with hands-on industry experience to help manufacturers achieve global market access for all types of medical devices and in vitro diagnostics (IVDs).
We provide strategic guidance and tailored support across a wide range of services, including:
- Regulatory Affairs. EU MDR, EU IVDR, FDA compliance, global regulatory strategy, CE marking, Pre-IDE, PMA, 510(k) submissions, and global medical device registration.
- Clinical Affairs & CRO Services. Clinical trial design and execution, clinical evaluations, post-market clinical follow-up, and regulatory due diligence.
- Quality & Compliance. Quality management system implementation, gap analysis, audits, and training.
- Global Representation. US Agent, EU Representative, UK Responsible Person, and China Agent for NMPA registration.
Whether you're navigating complex regulatory landscapes, optimizing clinical strategies, or ensuring compliance, Qserve is your dedicated partner in bringing innovative MedTech solutions to market.
