Head of QA/RA

Unity Partners exclusively on behalf of our MedTech partner

Right now, we’re seeking a Head of QA/RA for a dynamic medical device scale-up that develops groundbreaking technologies. In this role, you will support their inspiring mission to change the lives of over a million patients annually. You’ll join the company in an exciting phase of growth and innovation in which RA/QA is essential.

Key responsibilities:

• Lead the RA and QA organization to ensure compliance with the relevant applicable standards (MDR, FDA and ISO 13485).
• Report directly to the CEO and will be part of the Management Team.
• Develop, facilitate and implement regulatory strategies that will lead to successful product approvals like CE and FDA.
• Implement, maintain and optimize a QMS while instilling and fostering a culture of quality throughout the organization.
• Ensure quality & regulatory compliance in all phases of the product development and production processes
• Act as Management Representative and PRRC
• Risk Management, Internal/external audits, Management Review Process

Qualifications:

• At least 10 years’ experience in a similar position and with high-risk medical devices.
• In-depth knowledge of ISO 13485, 21 CFR 820, MDR, and other relevant standards/regulations
• Proven experience with MDR technical file submissions, obtaining CE, registrations and FDA approvals
• Strong experience in managing Notified Bodies
• Able to impact Management Team decisions
• Entrepreneurial mindset, skilled leader, strong communication, can look beyond QA/RA

Organization & Offer:

This is your chance to join a dynamic scale-up that’s leading change in the sector. You will be part of a passionate team that’s driving innovation and improving patient lives. You can expect a competitive salary and a generous benefits package. On top of that, opportunities for professional growth and leadership. Last but not least, a collaborative and flexible work environment that fosters innovation.

INTERESTED? If this opportunity resonates with you, please contact Christian Steenkamp for further information at +31 (0) 20 8938 606 or via email at christian@unitypartners.nl

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