Regulatory Affairs Manager - Arnhem, the Netherlands
The Role
As Regulatory Affairs Manager, you will take the lead in shaping and expanding the RA function. You'll coach, inspire, and guide the team toward exceptional results while ensuring that regulatory activities are fully aligned with the company's strategic direction. This is a pivotal leadership position where people management and regulatory expertise come together to drive impact across the organization.
Key Responsibilities
Lead, mentor, and develop the RA team, fostering a culture of ownership, accountability, and continuous improvement.
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Encourage and empower an international group of colleagues to achieve both personal and collective goals, strengthening collaboration across regions.
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Define priorities, establish measurable objectives, and ensure progress is monitored and achieved.
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Support professional development by acting as a trusted coach and mentor.
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Interpret changing legislation and standards, embedding them into practical QMS processes and procedures.
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Oversee and coordinate regulatory submissions for both new and existing products, ensuring alignment with the business strategy.
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Represent the RA function in cross-functional initiatives, integrating regulatory perspectives into company-wide decision-making.
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Stay current with evolving medical device regulations and share insights to strengthen knowledge across the organization.
Candidate Profile
Master's degree (or equivalent).
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Minimum 4 years of Regulatory Affairs experience in the medical device industry (class III, implants).
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At least 5 years of leadership experience, with a strong track record of team management.
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Knowledge of ophthalmology and intraocular lenses is highly desirable.
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Strong leadership skills with the ability to inspire and influence.
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Excellent communication and analytical abilities, combined with a structured and detail-oriented approach.
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