Manager Regulatory Affairs

Are you an experienced Regulatory Affairs leader with a passion for medical devices?

Are you looking for a motivated and diverse department to empower, guide and mentor?

Applied Medical gives you the opportunity to contribute to our global mission of high standards of integrity and social responsibility!

We are seeking an experienced Manager to support and develop our European RA Pre-Market, Post-Market and Operations teams. As part of a vertically integrated MedTech manufacturer and distributor, you will be at the heart of our European HQ and production plant.

In this varied and crucial role, you provide mid-term strategy, and plan business continuity and succession. As the link between the department and the rest of the organization, you also coordinate escalations to internal and external stakeholders.

To succeed in a dynamic, highly regulated and deadline-driven environment, you combine a confident and empowering management style, solid organization skills and the ability to adapt your approach to communicate effectively with a variety of stakeholder, including senior leadership, managers and team members.

Our international Regulatory Affairs department is based at our European headquarters in Amersfoort (NL). You’ll join a culture fueled by collaboration, innovation, and openness, driven by our mission to make a positive, meaningful difference, and report to the Director Regulatory Affairs / Quality Assurance in Europe.

Key Responsibilities

• Lead and support RA senior specialists and Team Leaders
• Define departmental goals in line with Applied Medical’s strategy as set out in collaboration with our US-based global HQs
• Guide the European Pre-Market, Post-Market and Operations teams in implementing set goals
• Monitor and analyze QMS process performance and quality objectives and drive process improvements
• Act as subject matter expert in QMS related processes, including external audits
• Ensure compliance with all applicable laws and regulations
• Create a personnel planning including onboarding and succession planning, team member development planning, etc.

• University degree (HBO, Bachelor or Master) in engineering, medical affairs, or life sciences related studies
• At least 5 years in a similar leadership role
• Experience in Medical Devices
• Excellent knowledge of major medical device standards and regulations
• Excellent oral and written communication skills in English
• Excellent reporting and presentation skills

• 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 with hybrid options
• 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! We kindly ask you to please include a motivation letter in your application.

For more information regarding our hiring process, click here. If you have any questions, feel free to contact us via recruitment-eu@appliedmedical.com or +31 (0)33 7548713.