Collaborate across bordersWork closely with our US-based RA and Engineering teams to align on regulatory strategies and maintain strong intercontinental relationships.Navigate complex interactions with diplomacy—balancing assertiveness with empathy to foster productive collaboration.Communicate effectively, delivering precise information promptly and in a clear manner.
Lead with vision and precisionAnalize complex information to make informed, strategic decisions on regulatory clear goals aligned with departmental strategy and ensure timely execution.Monitor team performance, assign responsibilities, and maintain high standards of accountability and quality.
Develop and empower your teamGuide a team of international RA specialists focused on pre-market activities and technical for succession, recruitment, onboarding, and training to ensure long-term team resilience and business continuity.Provide mentorship, feedback, and support to help team members grow and thrive.Cultivate a supportive and cooperative team environment that encourages suggestions for improvement and foster a cohesive atmosphere.
What you bring
Bachelor’s degree (HBO) in a relevant discipline, ie: engineering, medical affairs, or life sciences related studies
At least 3 years’ experience working within a regulatory affairs related discipline
At least 1 year experience in a supervisory role
Good knowledge of major medical device standards and regulations, including MDR
Excellent oral and written communication skills in English
What we offer
An international working environment, fueled by respect and a healthy work-life balance tailored to the business and team member’s needs
27 paid vacation days (based on fulltime contract) with option to purchase five additional days
This is mainly an on-site role
Commuting allowance of €0,23/km or an NS Business card subscription
A wide variety of internal trainings and development possibilities and a tuition program for external trainings
The opportunity to pro-actively work on your vitality and fitness
State-of-the-art facilities, including green areas, in-house restaurant and gym
Additional benefits, such as:Attractive pension scheme (your contribution at 4%, ours at 12%)€50 net monthly health insurance contributionTwo (paid) days per year dedicated to volunteering activitiesSeveral fun company events and meaningful initiatives organized throughout the year