Regulatory Affairs Manager
EPM Scientific is working with an innovative medical device company in the oncology diagnostics space. The organisation develops cutting-edge technologies to support the detection and analysis of cancer cells, enabling more personalised treatment pathways.
Role Overview
We are seeking a Regulatory Affairs Manager to lead regulatory activities across Europe and support international expansion. You will play a key role in ensuring compliance and driving approvals for novel diagnostic technologies.
Key Responsibilities
- Lead regulatory strategy and submissions (EU MDR and international markets)
- Manage and maintain CE marking and technical documentation
- Act as the primary contact for notified bodies and regulatory authorities
- Ensure compliance with relevant standards (e.g., ISO 13485, MDR, IVDR where applicable)
- Provide regulatory guidance to R&D and cross-functional teams
- Prepare and review documentation including clinical evaluations, risk management, and labeling
- Monitor regulatory developments and ensure ongoing compliance
- Support audits and inspections
Requirements
- Degree in Life Sciences, Engineering, or a related field
- 5+ years' experience in Regulatory Affairs within medical devices
- Strong knowledge of EU MDR (IVD experience is advantageous)
- Experience with CE marking and technical file preparation
- Understanding of clinical and post-market regulatory requirements
- Fluency in English (German is a plus)
What's On Offer
- Opportunity to join a fast-growing, innovation-driven MedTech company
- Exposure to cutting-edge oncology diagnostics technology
- Collaborative and dynamic work environment
- Competitive salary and career progression opportunities
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.