Regulatory Affairs and Product Management Lead

Vor 7 Tagen

Köln, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

We are seeking a highly skilled Regulatory Affairs and Product Management professional to lead the registration and market launch of a dedicated product at Vivalyx GmbH, a medical technology startup based in Aachen. As the Head of Regulatory Affairs and Product Management, you will be responsible for crafting and implementing strategies to meet regulatory requirements, from strategic planning to preparing technical documentation, in collaboration with our internal team and external partners.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with quality management standards such as ISO 13485 and 21 CFR 820
  • Prepare and submit technical documentation to regulatory bodies
  • Manage negotiations with partners and suppliers to ensure compliance with regulatory requirements
  • Collaborate with internal teams to develop and implement product development strategies

We offer a dynamic and highly skilled team environment, flexible working conditions, and opportunities for professional development and career growth. If you have a passion for working in medical technology development and a strong sense of ownership, drive, independence, and commitment, we encourage you to apply.

Requirements
  • Technical or scientific degree or equivalent training
  • Several years of experience in the medical device sector, ideally within a startup or SME
  • Expertise in regulatory affairs and project management, including liaising with regulatory bodies
  • Knowledge of standards such as ISO 13485, ISO 14971, 21 CFR 820, and MDR
  • Proficiency in Microsoft Office and fluent in English, both written and spoken

  • Regulatory Affairs and Product Management Expert

    Vor 4 Tagen

    Köln, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    We are seeking a highly skilled Regulatory Affairs and Product Management Expert to join our team at Vivalyx GmbH. As the Head of Regulatory Affairs and Product Management, you will lead the registration and market launch of a dedicated product. Your responsibilities will include crafting and implementing strategies to meet regulatory requirements, from...

  • Head of Regulatory Affairs and Product Management

    vor 2 Wochen

    Köln, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    About Vivalyx GmbHVivalyx GmbH is a medical technology startup based in Aachen, Germany, dedicated to improving the vitality and availability of donor organs. Our innovative approach aims to significantly enhance the lives of those suffering from organ failure.Job DescriptionWe are seeking a highly skilled and motivated individual to join our team as the...

  • Head of Regulatory Affairs and Product Management

    vor 2 Wochen

    Köln, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    About Vivalyx GmbHVivalyx GmbH is a medical technology startup based in Aachen, Germany, dedicated to developing innovative solutions for organ transplantation. Our mission is to improve the availability and vitality of donor organs, making a meaningful impact on people's lives.Job DescriptionWe are seeking a highly skilled and motivated individual to join...

  • Head of Regulatory Affairs and Product Management

    vor 2 Wochen

    Köln, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    About Vivalyx GmbHVivalyx GmbH is a medical technology startup based in Aachen, Germany, dedicated to developing innovative solutions for organ transplantation. Our mission is to improve the availability and vitality of donor organs, making a meaningful impact on people's lives.Job DescriptionWe are seeking a highly skilled and motivated individual to join...

  • Regulatory Affairs Specialist

    Vor 3 Tagen

    Köln, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    We are seeking a highly skilled Regulatory Affairs Specialist to lead the registration and market launch of a dedicated product at Vivalyx GmbH, a medical technology startup based in Aachen. As the go-to person for regulatory matters, you will craft and implement strategies to meet regulatory requirements, from strategic planning to preparing technical...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Köln, Nordrhein-Westfalen, Deutschland Vivalyx GmbH Vollzeit

    We are seeking a highly skilled Regulatory Affairs Specialist to lead the registration and market launch of a dedicated product at Vivalyx GmbH, a medical technology startup based in Aachen. As the go-to person for regulatory matters, you will craft and implement strategies to meet regulatory requirements, from strategic planning to preparing technical...

  • Regulatory Affairs Specialist

    vor 1 Woche

    Köln, Nordrhein-Westfalen, Deutschland GULP – experts united Vollzeit

    Exciting Opportunity for a Regulatory Affairs SpecialistWe are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team at GULP – experts united. As a key member of our team, you will be responsible for planning, organizing, and implementing national procedures for new marketing authorizations, marketing authorization...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Köln, Nordrhein-Westfalen, Deutschland GULP – experts united Vollzeit

    Exciting Opportunity for a Regulatory Affairs SpecialistWe are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team at GULP – experts united. As a key member of our team, you will be responsible for planning, organizing, and implementing national procedures for new marketing authorizations, marketing authorization...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Köln, Nordrhein-Westfalen, Deutschland GULP – experts united Vollzeit

    Exciting Opportunity for a Regulatory Affairs SpecialistWe are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team at GULP – experts united. As a key member of our team, you will be responsible for planning, organizing, and implementing national procedures for new marketing authorizations, marketing authorization...

  • Global Regulatory Toxicologist

    vor 4 Wochen

    Köln, Nordrhein-Westfalen, Deutschland ADAMA Vollzeit

    Job Title: Global Regulatory ToxicologistAt ADAMA, we are seeking a highly skilled Global Regulatory Toxicologist to join our team. As a key member of our regulatory affairs department, you will be responsible for providing expert toxicology support for new and existing product registrations, product stewardship, and registration maintenance.Key...

  • Global Regulatory Toxicologist

    vor 4 Wochen

    Köln, Nordrhein-Westfalen, Deutschland ADAMA Vollzeit

    Job Title: Global Regulatory ToxicologistAt ADAMA, we are seeking a highly skilled Global Regulatory Toxicologist to join our team. As a key member of our regulatory affairs department, you will be responsible for providing expert toxicology support for new and existing product registrations, product stewardship, and registration maintenance.Key...

  • Regulatory Affairs Specialist

    Vor 4 Tagen

    Köln, Nordrhein-Westfalen, Deutschland GULP – experts united Vollzeit

    We are seeking a highly motivated Regulatory Affairs Specialist to join our team at GULP – experts united. As a key member of our team, you will be responsible for planning, organizing, and implementing national procedures for new marketing authorizations, marketing authorization renewals, and marketing authorization variations for medicinal products.Key...

  • Regulatory Affairs Specialist

    Vor 2 Tagen

    Köln, Nordrhein-Westfalen, Deutschland GULP – experts united Vollzeit

    We are seeking a highly motivated Regulatory Affairs Specialist to join our team at GULP – experts united. As a key member of our team, you will be responsible for planning, organizing, and implementing national procedures for new marketing authorizations, marketing authorization renewals, and marketing authorization variations for medicinal products.Key...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Köln, Nordrhein-Westfalen, Deutschland GULP – experts united Vollzeit

    Are you looking for a new challenge in the pharmaceutical industry? We have an exciting opportunity for a Regulatory Affairs Manager to join our team at GULP – experts united.About the RolePlan, organize, and implement national procedures for new marketing authorizations, marketing authorization renewals, and marketing authorization variations for...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Köln, Nordrhein-Westfalen, Deutschland GULP – experts united Vollzeit

    Are you looking for a new challenge in the pharmaceutical industry? We have an exciting opportunity for a Regulatory Affairs Manager to join our team at GULP – experts united.About the RolePlan, organize, and implement national procedures for new marketing authorizations, marketing authorization renewals, and marketing authorization variations for...

  • Regulatory Affairs Specialist

    Vor 5 Tagen

    Köln, Nordrhein-Westfalen, Deutschland GULP – experts united Vollzeit

    We are seeking a highly motivated Regulatory Affairs Specialist to join our team at GULP – experts united. As a key member of our team, you will be responsible for planning, organizing, and implementing national procedures for new marketing authorizations, marketing authorization renewals, and marketing authorization variations for medicinal products.Key...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Köln, Nordrhein-Westfalen, Deutschland Walter-Fach-Kraft Personal GmbH Vollzeit

    JobbeschreibungWir suchen einen erfahrenen Regulatory Affairs-Experten, der unser Team in der Kosmetikbranche unterstützt.HauptraumRegulatory Affairs-AssistentTeamleiter Regulatory AffairsAls Regulatory Affairs-Assistent werden Sie sich auf die Beurteilung und Gewährleistung der Produktsicherheit konzentrieren. Sie werden Produkttexte und...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Köln, Nordrhein-Westfalen, Deutschland Walter-Fach-Kraft Personal GmbH Vollzeit

    JobbeschreibungWir suchen einen erfahrenen Regulatory Affairs-Experten, der unser Team in der Kosmetikbranche unterstützt.HauptraumRegulatory Affairs-AssistentTeamleiter Regulatory AffairsAls Regulatory Affairs-Assistent werden Sie sich auf die Beurteilung und Gewährleistung der Produktsicherheit konzentrieren. Sie werden Produkttexte und...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Köln, Nordrhein-Westfalen, Deutschland Walter-Fach-Kraft Personal GmbH Vollzeit

    JobbeschreibungWir suchen einen erfahrenen Regulatory Affairs-Experten, der unser Team in der Kosmetikbranche unterstützt.HauptraumRegulatory Affairs-AssistentTeamleiter Regulatory AffairsAls Regulatory Affairs-Assistent werden Sie sich auf die Beurteilung und Gewährleistung der Produktsicherheit konzentrieren. Sie werden Produkttexte und...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Köln, Nordrhein-Westfalen, Deutschland Walter-Fach-Kraft Personal GmbH Vollzeit

    JobbeschreibungWir suchen einen erfahrenen Regulatory Affairs-Experten, der unser Team in der Kosmetikbranche unterstützt.HauptraumRegulatory Affairs-AssistentTeamleiter Regulatory AffairsAls Regulatory Affairs-Assistent werden Sie sich auf die Beurteilung und Gewährleistung der Produktsicherheit konzentrieren. Sie werden Produkttexte und...