Reporting to your manager, Head of RA & QA, and as part of the regulatory team, you will share responsibility for all the Regulatory Affairs within the company. Several regulatory consultants are involved, each with their own expertise to help us crack the most difficult regulatory challenge. There are no comparable devices on the market yet; this company will be the first company in the world to receive CE approval on the device. Your timing is perfect: you will be joining the company during probably the most interesting and challenging period, as the next 12 months will be incredibly important. Additionally, the company is preparing an FDA submission. The system consists of a variety of subsystems and disposables, which each bring their own technical, clinical and regulatory challenges. Building a new device means you have to invent quite a lot, meaning: interpret regulation and translate it to the device. You need to be confident enough to bring your convictions to the technical group and stand your ground, but also be able to do this in an amicable way.
Your key responsibilities:
- Stay updated on changes in regulations and guidelines and develop strategies to ensure compliance
- Provide input and guidance to cross-functional teams regarding regulatory requirements, timelines and strategies for successful market access
- Participate in post-market surveillance activities after market access
- Assist in preparing for and participating in regulatory audits and inspections.
What's asked for:
- At least 3 years of experience in Regulatory Affairs for medical devices, backed with a BSc in a technical or scientific field
- Demonstrable achievements in bringing innovative MedTech products to the market and obtaining regulatory approvals (including CE and preferably FDA), strong knowledge of MDR
- Excellent written English communication skills, in particular strong in regulatory writing. You’re a confident communicator, with a positive - somewhat scientific - mindset, you know how to fail and get back on your feet again
- Experience with and knowledgeable in a multitude of widely used standards such as risk management (ISO 14971), usability (IEC 62366), biocompatibility (ISO 10993), basic safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software development (IEC 62304).
Company: Our customer is an innovative and fast growing medtech scale-up company from Dutch origin. They have developed breakthrough technology that will offer wonderfull changes in healthcare. The company has a pioneering mindset. They are open minded teamplayers and their people work with great dedication to bring the best out for patient care. Improving the lives of millions of patients runs through the veins of their business. Their extraordinary team of over 50 people loves to work on the toughest challenges to find cutting-edge solutions. They realize breakthroughs and change the future of health care. What's not to love about that? Their can-do mentality and passion to work on the toughest challenges to find cutting-edge solutions leads them to a huge success: the product launch at the end of 2024.
What's their offer:
- Competitive salary including pension plan
- 24 days of annual leave based on a full-time position
- Stock options, to become ‘co-owner’ of a fast-growing company
- Open to hybrid work models
- Working together in a high-skilled team with their home base in Utrecht
- Frequent out-of-work activities with the team (such as their ski-trip)
- Annual training budget of 2000 euro's
- Opportunity to be key shaper of a new global industry niche: autonomous medical robotics
They offer an environment where you can make a lot of impact, as you are joining a growing scale-up in MedTech. Their team of driven and talented colleagues enjoys solving the challenges in developing, manufacturing, and completing our breakthrough medical device. While working in an open culture, they strive for excellence in all domains. They believe in taking courage and like to challenge each other. They learn and teach, regardless of age, nationality or gender.
Location: Utrecht, The Netherlands
Soort dienstverband: Vaste baan, Fulltime
Rooster:
- Dagdienst
- ma-vr
Secundaire arbeidsvoorwaarden:
- Aandelenopties
- Bedrijfsopleiding
- Mogelijkheid tot promotie
- Pensioen
- Werk vanuit huis
Soorten aanvullende vergoedingen:
- Vakantiegeld
Screeningsvragen:
- Do you have experience obtaining regulatory approvals for medical products?
Opleiding:
- HBO (Vereist)
Ervaring:
- regulatory affairs: 3 jaar (Vereist)
Taal:
- Engels (Vereist)
Werklocatie: Fysiek
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