QA/RA Manager

Unity Partners exclusively on behalf of our MedTech partner

Right now, we’re seeking a QA/RA Manager 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.

As QA/RA Manager, you’ll be responsible for among others optimizing the QMS, CE submission, obtain FDA approval and work closely together with the QA/RA Director.

Key responsibilities:

• Develop/ maintain QMS compliance in accordance with ISO 13485:2016, 21CFR 820, MDR, etc.
• First-line responsibility in setting up, guiding and (co)-creating regulatory documentation for certification and approval of the medical devices.
• Prepare the regulatory submissions in close cooperation with the team and other stakeholders.
• Elevate quality and regulatory awareness within the company.

Qualifications:

• At least a Bachelor’s degree in a life sciences or technical area.
• A minimum of 4 years of experience in a similar position.
• Knowledge of ISO 13485, 21 CFR 820, MDR, and other relevant standards/regulations.
• Proven experience with MDR technical file submissions, registrations and/or FDA approvals.
• Experience with medical device packaging, sterilization, and aging processes is a plus.
• Effective interpersonal communication skills, accurate, detail-oriented, self-motivated.

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