Senior Quality & Regulatory Affairs Manager

Senior Quality and Regulatory Affairs Manager

Our client is seeking an experienced and motivated Senior Quality and Regulatory Affairs Manager to join their fast-growing medical device company in Munich, Germany.

In this role, you will play a crucial part in maintaining global quality and regulatory compliance. You'll have the opportunity to collaborate with internal teams, mentor junior staff, and manage important relationships with regulatory authorities and external partners.

Key Responsibilities:

• Manage and maintain technical documentation for product submissions, changes, and quality management (QM)-related documents.
• Mentor and train staff across various departments to ensure effective execution of regulatory responsibilities.
• Conduct compliance audits, including assessments of vendors, clients, and subcontractors.
• Support and manage external audits with notified bodies and competent authorities, overseeing risk management and post-market surveillance activities.
• Oversee the establishment, maintenance, and optimization of Quality Systems to ensure full regulatory compliance..
• Act as a primary contact for regulatory agencies, assisting with negotiations and managing interactions during inspections and audits.

Key Qualifications:

• Bachelor’s degree in Engineering, Biomedical Sciences, or a related field (Master’s degree or MBA preferred).
• Minimum of 4 years of experience in quality management and regulatory affairs within the medical device industry.
• Proven experience with regulatory submissions and approvals such as MDD/MDR.
• Experience with regulatory audits and a deep understanding of medical device standards.
• Flexible, goal-driven, and a collaborative team player focused on delivering results.

This role offers a unique opportunity to contribute to a growing company and shape the development of cutting-edge medical technologies aimed at improving patient care.

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 Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
dominika.wyrwinska@adaptivelifescience.com

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