QARA Engineer

Quality Assurance & Regulatory Affairs Engineer

Do you have an eye for detail and a passion for patient safety?

Ensure the safety, quality, and compliance of medical devices that support life-changing procedures.

Join a global leader focusing on cutting-edge medical technologies used in precision surgery.

Apply Now!

Role Incentives

• Competitive salary & additional benefits
• 30 days of vacation plus additional options for time off when needed
• Hybrid flexibility & flexible working hours
• Health & wellness benefits
• Professional development & lifelong learning opportunities
• Supportive team with flat hierarchies

Your Key Responsibilities

• Establish quality and regulatory requirements from project initiation to final approval
• Oversee approval testing and ensure accurate technical documentation (MDR, ISO 13485, IEC 60601-1)
• Implement and manage risk management activities (ISO 14971).
• Serve as the link between quality assurance, regulatory affairs, and project teams.

Requirements

• Degree in biomedical, electrical, or mechanical engineering (or equivalent)
• 2+ years of experience in MedTech quality and regulatory processes
• Skilled in Technical Documentation (MDR, ISO 13485, IEC 60601-1, ISO 14971); FDA experience is a plus
• Experience with safety & performance testing of active medical devices.
• Familiarity with conformity assessments & audits
• Strong problem-solving, communication, and teamwork skills
• Fluent in English, B2+ German required

Reach out to Vivien Urban for more information about the company culture, and long-term development plans.
 
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.

Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:

• Expert advice on your CV and cover letter
• Guidance on salary expectations
• Personalized interview preparation
• Connections to exclusive job opportunities
• Assistance in negotiating the best possible offers
• 50% of the CVs we send to clients are accepted
• Accepted or declined, either way we will provide you with feedback

We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.
 
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
If you are interested in this role, please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
 
Vivien.urban@adaptivelifescience.com
+49 30 16639819