Team Leader Regulatory Affairs - Pre Market

Applied Medical; Amersfoort; On-site; EUR 70.000 - 100.000; Full time

Job summary

Applied Medical is seeking a Team Leader for Regulatory Affairs in Amersfoort. This key role involves strategizing around regulatory clear goals and fostering a supportive and efficient team environment. Candidates should possess a Bachelor’s degree in a relevant field and have a solid background in regulatory affairs, alongside essential leadership skills. This opportunity offers a blend of professional development and a healthy work-life balance within an international environment.

Benefits

27 paid vacation days

Commuting allowance of €0.23/km

Internal trainings and development

State-of-the-art facilities

Attractive pension scheme

Monthly health insurance contribution

Volunteering opportunities

Company events

Qualifications

• At least 3 years’ experience in regulatory affairs.
• 1 year in a supervisory role.
• Good knowledge of medical device standards like MDR.

Responsibilities

• Collaborate with US-based RA and Engineering teams.
• Analyze information for strategic regulatory decisions.
• Guide and mentor an international team of RA specialists.

Skills

Communication

Team Leadership

Regulatory Knowledge

Education

Bachelor's degree (HBO) in relevant discipline

Job description

Social network you want to login/join with:

Team Leader Regulatory Affairs - Pre Market, Amersfoort

Client:

Applied Medical

Location:

Amersfoort, Netherlands

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

f820ba182d6c

Job Views:

6

Posted:

01.07.2025

Expiry Date:

15.08.2025

Job Description:

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: Analyze 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 team: Guide a team of international RA specialists focused on pre-market activities and technical aspects 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 fosters a cohesive atmosphere.

What you bring

• Bachelor’s degree (HBO) in a relevant discipline, e.g., 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 full-time contract) with the 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 proactively 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