Medical Device Regulatory Lead

Vor 7 Tagen

Aachen, Nordrhein-Westfalen, Deutschland Chameleon International Search Ltd Vollzeit

Chameleon International Search Ltd is partnering with a leading Medical Device organisation to fill a Head of Regulatory Affairs & Quality Management role.

Our client is a well-established international group with a growing global footprint across Europe and Asia. The business is highly innovative in their product research and development, retaining an entrepreneurial and growth-minded strategy.

This role will hold full responsibility for their Quality Systems & Regulatory Affairs function for their German-based subsidiary, with responsibility for:
• Experience in class 3 medical devices is preferable
• In-depth knowledge of legal and regulatory requirements for medical devices under MDR
• English and German language competence

As a key member of the team, you will be responsible for ensuring compliance with regulatory requirements, managing quality systems, and driving business growth through strategic planning and execution.

If you have a strong background in regulatory affairs and quality management, and are looking for a challenging role that will allow you to make a real impact, then this could be the opportunity for you.

**Key Responsibilities:**
• Develop and implement quality systems and regulatory strategies to ensure compliance with MDR and other relevant regulations
• Manage and maintain relationships with regulatory authorities and industry stakeholders
• Conduct audits and assessments to ensure quality and regulatory compliance
• Provide training and guidance to colleagues on regulatory requirements and quality systems
• Collaborate with cross-functional teams to drive business growth and improve operational efficiency

**Requirements:**
• Proven experience in regulatory affairs and quality management, preferably in the medical device industry
• Strong knowledge of MDR and other relevant regulations
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Strong analytical and problem-solving skills

If you are a motivated and experienced professional looking for a new challenge, please submit your application.

  • International Medical Device Registration Specialist

    Vor 6 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland DynaMesh® - FEG Textiltechnik Vollzeit

    We are seeking a highly organized and detail-oriented individual to join our Market Access & Marketing team at DynaMesh® - FEG Textiltechnik. As a key member of our team, you will play a crucial role in ensuring the compliance of our medical devices with international regulations.Key Responsibilities:Compile, edit, and update international registration...

  • International Medical Device Registration Specialist

    Vor 6 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland DynaMesh® - FEG Textiltechnik Vollzeit

    We are seeking a highly organized and detail-oriented individual to join our Market Access & Marketing team at DynaMesh® - FEG Textiltechnik. As a key member of our team, you will play a crucial role in ensuring the compliance of our medical devices with international regulations.Key Responsibilities:Compile, edit, and update international registration...

  • Regulatory Affairs Director

    vor 1 Tag

    Aachen, Nordrhein-Westfalen, Deutschland Chameleon International Search Ltd Vollzeit

    Chameleon International Search Ltd is partnering with a leading Medical Device organisation to find a Head of Regulatory Affairs & Quality Management professional. Our client is a well-established international group with a growing global footprint across Europe and Asia. They are highly innovative in their product research and development, retaining an...

  • Regulatory Affairs Director

    vor 1 Tag

    Aachen, Nordrhein-Westfalen, Deutschland Chameleon International Search Ltd Vollzeit

    Chameleon International Search Ltd is partnering with a leading Medical Device organisation to find a Head of Regulatory Affairs & Quality Management professional. Our client is a well-established international group with a growing global footprint across Europe and Asia. They are highly innovative in their product research and development, retaining an...

  • Regulatory Affairs Specialist

    vor 1 Woche

    Aachen, Nordrhein-Westfalen, Deutschland Chameleon International Search Ltd Vollzeit

    Chameleon International Search Ltd is partnering with a leading Medical Device organisation to fill a critical role in their Regulatory Affairs and Quality Management team.The company is a well-established international group with a strong presence in Europe and Asia, known for their innovative approach to product research and development and their...

  • Regulatory Affairs Specialist

    vor 1 Woche

    Aachen, Nordrhein-Westfalen, Deutschland Chameleon International Search Ltd Vollzeit

    Chameleon International Search Ltd is partnering with a leading Medical Device organisation to fill a critical role in their Regulatory Affairs and Quality Management team.The company is a well-established international group with a strong presence in Europe and Asia, known for their innovative approach to product research and development and their...

  • Regulatory and Product Management Lead

    vor 1 Woche

    Aachen, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    About Vivalyx GmbHVivalyx GmbH is a medical technology startup dedicated to developing innovative solutions for organ failure. Our mission is to improve the vitality and availability of donor organs through groundbreaking technology.Job SummaryWe are seeking a highly skilled and motivated individual to join our team as the Head of Regulatory Affairs and...

  • Head of Regulatory Affairs and Quality Management

    Vor 4 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland Chameleon International Search Ltd Vollzeit

    Chameleon International Search Ltd is partnering with a leading Medical Device organization to find a seasoned professional for a Head of Regulatory Affairs & Quality Management role.The company is a well-established international group with a strong presence in Europe and Asia, known for its innovative approach to product research and development and its...

  • Head of Regulatory Affairs and Quality Management

    Vor 4 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland Chameleon International Search Ltd Vollzeit

    Chameleon International Search Ltd is partnering with a leading Medical Device organization to find a seasoned professional for a Head of Regulatory Affairs & Quality Management role.The company is a well-established international group with a strong presence in Europe and Asia, known for its innovative approach to product research and development and its...

  • Lead Clinical Research Associate

    vor 4 Monaten

    Aachen, Nordrhein-Westfalen, Deutschland Johnson & Johnson Vollzeit

    Abiomed is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and...

  • Product Development Engineer

    vor 2 Wochen

    Aachen, Nordrhein-Westfalen, Deutschland VYGON GmbH & Co Vollzeit

    Key Responsibilities:We are seeking a highly motivated and experienced Development Engineer to join our team at VYGON GmbH & Co. in the development of new medical products.Key Accountabilities:Collaborate with cross-functional teams to design, develop, and launch new medical devices, with a focus on vascular access solutions.Lead development projects,...

  • Regulatory Affairs Specialist

    Vor 2 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    About Vivalyx GmbHWe are a medical technology startup based in Aachen, dedicated to developing innovative solutions to improve the availability of donor organs. Our mission is to save lives by addressing organ failure.Job DescriptionWe are seeking a highly skilled and motivated individual to join our team as the Head of Regulatory Affairs and Product...

  • Regulatory Affairs Specialist

    Vor 2 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    About Vivalyx GmbHWe are a medical technology startup based in Aachen, dedicated to developing innovative solutions to improve the availability of donor organs. Our mission is to save lives by addressing organ failure.Job DescriptionWe are seeking a highly skilled and motivated individual to join our team as the Head of Regulatory Affairs and Product...

  • Head of Regulatory Affairs and Product Management

    Vor 6 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    Vivalyx GmbH is a medical technology startup that aims to revolutionize the field of organ transplantation. We are seeking a highly skilled and experienced professional to join our team as the Head of Regulatory Affairs and Product Management.About the RoleThe successful candidate will be responsible for leading the registration and market launch of our...

  • Head of Regulatory Affairs and Product Management

    Vor 6 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    Vivalyx GmbH is a medical technology startup that aims to revolutionize the field of organ transplantation. We are seeking a highly skilled and experienced professional to join our team as the Head of Regulatory Affairs and Product Management.About the RoleThe successful candidate will be responsible for leading the registration and market launch of our...

  • Head of Quality and Compliance

    vor 1 Woche

    Aachen, Nordrhein-Westfalen, Deutschland Chameleon International Search Ltd Vollzeit

    Chameleon International Search Ltd is partnering with a leading Medical Device organisation to fill a critical role in their Regulatory Affairs and Quality Management department.The company is a well-established international group with a strong presence in Europe and Asia, known for their innovative approach to product research and development and their...

  • Head of Quality and Compliance

    Vor 7 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland Chameleon International Search Ltd Vollzeit

    Chameleon International Search Ltd is partnering with a leading Medical Device organisation to fill a critical role in their Regulatory Affairs and Quality Management department.The company is a well-established international group with a strong presence in Europe and Asia, known for their innovative approach to product research and development and their...

  • Medical Professional

    Vor 6 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland Luisenhospital Aachen Vollzeit

    Join Our Team as a Medical ProfessionalWe are a dynamic and highly motivated team at Luisenhospital Aachen, seeking a skilled Medical Professional to join our gastroenterology department.About the RoleAssist in the daily operations of our outpatient clinic, providing exceptional patient care and support.Collaborate with our medical team to ensure seamless...

  • Medical Professional

    Vor 5 Tagen

    Aachen, Nordrhein-Westfalen, Deutschland Luisenhospital Aachen Vollzeit

    Join Our Team as a Medical ProfessionalWe are a dynamic and highly motivated team at Luisenhospital Aachen, seeking a skilled Medical Professional to join our gastroenterology department.About the RoleAssist in the daily operations of our outpatient clinic, providing exceptional patient care and support.Collaborate with our medical team to ensure seamless...

  • Medical Product Development Engineer

    vor 4 Wochen

    Aachen, Nordrhein-Westfalen, Deutschland VYGON GmbH & Co. KG Vollzeit

    Company Overview:VYGON GmbH & Co. KG is a prominent entity within the international VYGON group, specializing in the production of advanced medical devices designed for single use. Our dedicated team of 350 professionals based in Aachen is committed to the development, manufacturing, and distribution of innovative solutions across various medical...