Quality Management and Regulatory Affairs Specialist

Are you ready to take the next step in your career and make a significant impact in the field of quality management and regulatory affairs? We are seeking a passionate and skilled professional to join a dynamic medical device company with a wide variety of products, distributing to 90+ countries!

In this role, you will be instrumental in maintaining and enhancing the quality management system, ensuring compliance with industry standards, and driving continuous improvement in processes and products. If you thrive in a challenging environment and are committed to excellence, this opportunity is for you!

Key Responsibilities

• Maintain and continuously develop the quality management system in accordance with ISO 13485 and MDSAP
• Prepare and implement internal and external audits and monitor certification processes
• Process complaints effectively and efficiently
• Plan, implement, and monitor validation and verification activities
• Create and maintain technical documentation in accordance with MDR
• Act as the internal and external contact for regulatory issues and projects
• Document and evaluate quality indicators for continuous improvement
• Compile registration documents for international registrations
• Serve as the contact person for regulatory authorities
• Manage international registration projects

Required Qualifications and Skills

• Degree in engineering, medical technology, quality management, or a comparable qualification
• 3 years of professional experience in a regulatory environment, with experience in quality management, ideally in medical technology
• Knowledge of ISO 13485
• Strong analytical thinking and a structured, independent working style
• High level of reliability and initiative
• Excellent presentation, moderation, and communication skills
• Ability to work independently while being team-oriented
• Experience in project and time management

Benefits and Perks

• Competitive salary and performance-based bonuses
• Opportunities for professional development and continuous learning
• Flexible working hours and the possibility of remote work
• Supportive and collaborative team environment
• Comprehensive health and wellness programs

Application Instructions
If you are passionate about making a difference in the medical field and meet the qualifications outlined above, we encourage you to apply. Please submit your resume and a cover letter to Rebecca.stevens@adaptivelifescience.com detailing your relevant experience and motivation for this role, or call +49 30 16 63 93 35 for more information.

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.