Are you ready to lead innovation and make a meaningful difference in healthcare technology?

Do you want to develop cutting-edge mechatronic surgical instruments that improve patient outcomes?

Join our client's team and play a pivotal role in transforming patient care through ground-breaking medical technology!
 

Key Responsibilities:

• Collaborate on the design and development of mechatronic surgical instruments that enhance patient safety and precision in surgeries.
• Translate design inputs into engineering specifications and create sub-system level designs.
• Innovate and create prototypes to demonstrate proof of concept and feasibility for new technologies.
• Take ownership of engineering documentation, maintaining the Design History File to support product development.
• Work within R&D processes, following design controls and risk management aligned with the Quality Management System.
• Tackle complex engineering challenges, applying expertise while managing tasks and priorities effectively.

Requirements:

• 3–5 years of experience in technical product development in the MedTech industry.
• Strong proficiency in technical documentation and Quality Management System (QMS) processes.
• Familiarity with regulatory frameworks, including FDA regulations, EU MDR, and design controls in regulated environments.
• A Bachelor’s or Master’s degree in engineering or a related field.
• Experience with design and concept generation tools (e.g., SolidWorks, Fusion 360).
• Strong problem-solving skills, with the ability to manage tasks and priorities effectively.
• Passion for working in a fast-paced start-up environment where your contributions shape outcomes.

What’s in it for you?

• Innovative Impact: Contribute to improving lives by transforming surgical technology to make procedures safer and more patient-focused.
• Empowering Culture: Be part of an inclusive team that values your unique perspective.
• Supportive Team: Work alongside talented professionals where your ideas truly matter.
• Flexibility: Enjoy a hybrid working model that promotes a healthy work-life balance.
• Room to Grow: As part of a fast-growing start-up, there are ample opportunities for professional development and career growth.
• Meaningful Work: Your contributions will directly impact patient outcomes and the future of healthcare.

If you’re passionate about shaping the future of healthcare and thriving in an innovative environment, apply now or contact Hollie Dear at Adaptive Life Science for more information!

Head of Quality Management & Regulatory Affairs

Location: Marburg, Germany (Hybrid)

Overview:

This company has been developing and manufacturing innovative in vitro diagnostics and medical devices for over 40 years and selling them globally.

Benefits:
 

1. Attractive Remuneration: Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work. Company Bonus Scheme provided
2. Work with Management: This position allows you to collaborate with senior management, internal departments, and external stakeholders
3. Permanent Full-Time Position: Permanent employment in a leading global company with secure future prospects.
4. 30 Days Holiday and other tailored benefits.
5. Responsible and varied tasks that allow you to have an interesting and varied job across RAQM.
6. Team Events; benefit from being part of a wider global operation.

Tasks:

The Head of QM & RA oversees Quality Management and Regulatory Affairs, ensuring compliance, continuous QMS improvement, and effective coordination between management, departments, and stakeholders.

Key Responsibilities:

Leadership & Team Management:

• Oversee the QARA team, including task delegation and absence planning.
• Facilitate communication between management, departments, and team members.
• Ensure smooth collaboration and workflow across projects.

Quality Management:

• Maintain and enhance the QMS (DIN EN ISO 13485).
• Oversee technical documentation and compliance with EU Regulation 2017/746 (IVDR).
• Lead CAPA, root cause analysis, complaint management, and post-market surveillance.
• Act as Management Representative, conducting QMS reviews and reporting to leadership.
• Ensure regulatory compliance and drive process improvements.

Regulatory Affairs:

• Manage all regulatory compliance activities and act as PRRC.
• Oversee product registrations for domestic and international markets.
• Provide necessary certifications and handle recalls/field safety notices.

Safety & Compliance:

• Serve as Deputy Radiation Protection Officer, ensuring radiation safety compliance.
• Advise as a Medical Device Consultant and conduct internal audits.

Your Profile:
 

•  Bachelor or Master’s degree in biotechnology, Biopharmaceutical Technology, or a related field.
•  At least 3 years of experience in a role focused on technical documentation, regulatory affairs, or quality management.
•  Certified Internal Auditor.
•   Completion of PRRC training (2024) or willingness to complete.
•  Proficiency in DIN EN ISO 13485 and EU IVDR standards.
•  Strong leadership and team management skills.
•  Analytical and organizational abilities.
•  Fluent in English and German proficiency is a must.

For more information, please contact Luke Fines:
luke.fines@adaptivelifescience.com
+49 30 1663 4514

 

Regulatory Affairs Specialist

Are you passionate about bringing life changing medical devices onto the market on an international scale?

Join our client, a market leading developer, manufacturer and distributor of implants and devices for ophthalmic surgery with over four decades of history.

Apply now and use your skills to help restore the best possible vision to patients worldwide!

Benefits

• Varied and responsible activities in an innovative and future-oriented company
• Collegial support culture
• Flat hierarchies & Short decision-making processes
• Family friendliness
• 30 days of vacation per year
• Christmas and holiday bonuses

 
Your Key Responsibilities

• Approval and registration of medical devices globally
• Preparation of certification and legalization documents
• Maintenance and development of technical documentation, including risk management
• Support for EU MDR implementation and approval
• Regulatory contact for internal teams and business partners

Requirements

• Successfully completed degree in engineering, medical technology or similar
• Min. 1-3 years of experience in medical device Regulatory Affairs
• Knowledge of regulatory requirements e.g. MDR, MDD, FDA, NMPA, EN ISO 13485, EN ISO 14971
• Resilience, structured, solution-oriented and independent way of working
• Ability to work in a team and assertiveness
• Strong service orientation, friendliness and professional manners
• Confident use of MS Office
• Very good knowledge of German and English

Ophthalmological knowledge is a plus!

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