Team Leader Regulatory Affairs - Pre Market

Overview:

Job Description:

Are you a confident Regulatory Affairs professional with a solid grasp of MDR and experience with notified bodies?

Are you looking for the opportunity to lead a diverse team, make strategic decisions, and collaborate across international departments?

Applied Medical is hiring a Team Leader Regulatory Affairs to guide our 4 specialist (with different levels of experience) that focus on European and UK pre-market activities including technical file development and maintenance.

You will play a pivotal role in ensuring compliance with the Medical Devices Regulation, support business continuity and team development, while navigating complex regulatory landscapes and fostering strong international partnerships with the global headquarters in USA.

This is a great opportunity to join a growing and innovative medical devices company, and have a positive impact on a motivated and diverse workforce. Your ability to work assertively yet diplomatically will allow you to communicate with senior leadership, fellow managers and team members, mainly from Engineering and Quality, both based in Amersfoort as well as in California. You will act as our subject matter expert, strengthen relationships and drive or facilitate change when needed. You'll join a culture fueled by collaboration, innovation, and openness, driven by our mission to make a positive, meaningful difference.

Our international Regulatory Affairs department is based at our European headquarters in Amersfoort (NL), where we develop, manufacture, sterilize and distribute our medical devices.

Within Applied Medical the title of this position is Team Leader Regulatory Affairs, reporting to the Manager Regulatory Affairs.

Key Responsibilities

Collaborate across borders
Work 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 precision
Analize complex information to make informed, strategic decisions on regulatory priorities.
Set 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 team
Guide a team of international RA specialists focused on pre-market activities and technical files.
Plan 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.
Requirements:
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
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 contribution
Two (paid) days per year dedicated to volunteering activities
Several fun company events and meaningful initiatives organized throughout the year

At Applied Medical, we are committed to make a meaningful, positive difference, each and every day. Within our European headquarters in Amersfoort (NL), we develop, manufacture and support the implementation of our advanced medical devices across Europe and the MENA region. Applied's team members enjoy working in an environmentally friendly and international environment, in which people of diverse backgrounds are valued, challenged, and acknowledged. We support our team members by giving them opportunities of ongoing learning and education, possibilities to take part in community volunteering activities and a variety of onsite exercise classes and health activities.

If you are passionate about working in an organization that allows you to make decisions based upon what is right for the patient, customer, community and environment, Applied Medical is the place for you.

Interested?

Would you like to be part of our expanding team? If the answer is yes, we'd love to get to know you and look forward to hearing from you!

For more information regarding our hiring process, click here. If you have any questions, feel free to contact us via or (0).

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