Manager Regulatory Affairs

Manager Regulatory Affairs

Applied Medical

Amersfoort, Netherlands

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.

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.

What you bring

• 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.

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