Regulatory Affairs Specialist

Vor 7 Tagen

Deutschland Indegene Vollzeit
About Indegene

We are a technology-driven healthcare solutions provider, dedicated to empowering healthcare organizations to be future-ready. Our purpose is to enable accelerated, global growth opportunities for talented individuals who are bold, industrious, and nimble. At Indegene, you'll experience a unique career journey that celebrates entrepreneurship, passion, innovation, collaboration, and empathy.

Job Summary

We're seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Compliance Expert, you will provide expert regulatory advice to our team, ensuring client project requirements are met. Your responsibilities will include:

Key Responsibilities:
  • Providing guidance on standards pertaining to advertising and promotion of medical devices in Germany (and if possible, in EU and global regions).
  • Providing guidance on Germany Regulatory Requirements for promotional material review for medical devices.
  • Providing guidance on review workflow for medical device promotional materials for Germany market.
  • Providing strategic input and guidance on regulatory affairs matters, including understanding the collaboration between global and local markets for medical device promotional materials and associated review workflow for repurposing content, understanding regulatory submission guidelines, filing, negotiations, and amendments, which includes obtaining, assessing and summarizing scientific and other technical information specific for Germany market.
Requirements:
  • Life science graduate/post-graduate.
  • Regulatory Affairs/Compliance professional with experience in Medical Device regulations and standards for device promotion and scientific communication, with 2 years' experience in review and approval of medical device promotional and non-promotional materials.
  • Strong foundation in medical device regulatory affairs, with a total of 2-3 years working with a range of medical devices (Class 2 and above is preferred).
  • Has experience with and understands Germany, EU and global medical device regulations.
  • Ability to build and maintain strong and collaborative working relationships with internal and external contacts.
  • Ability to analyze complex regulatory issues, propose effective solutions, and make sound recommendations to stakeholders.
About You

We're looking for a talented individual who is passionate about regulatory affairs and has a strong foundation in medical device regulations. If you're a team player with excellent communication skills and a keen eye for detail, we'd love to hear from you.

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Deutschland EPM Scientific Vollzeit

    Job DescriptionRegulatory Affairs Specialist (m/f/d)You will play a critical role in ensuring the company's compliance with national and international regulatory requirements. As a Regulatory Affairs Specialist, you will be responsible for:Creating and updating 510(k) regulatory documentation for devices and instruments, including Premarket Notification and...

  • Regulatory Affairs Specialist

    Vor 7 Tagen

    Deutschland EPM Scientific Vollzeit

    Job DescriptionRegulatory Affairs Specialist (m/f/d)You will play a critical role in ensuring the company's compliance with national and international regulatory requirements. As a Regulatory Affairs Specialist, you will be responsible for:Creating and updating 510(k) regulatory documentation for devices and instruments, including Premarket Notification and...

  • Regulatory Affairs Specialist

    Vor 7 Tagen

    Deutschland Indegene Vollzeit

    Job DescriptionIndegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Compliance Expert, you will be responsible for providing expert regulatory advice to our team and ensuring client project requirements are met.Key Responsibilities:Provide guidance on standards pertaining to advertising and promotion of...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Deutschland Indegene Vollzeit

    Job DescriptionIndegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Compliance Expert, you will be responsible for providing expert regulatory advice to our team and ensuring client project requirements are met.Key Responsibilities:Provide guidance on standards pertaining to advertising and promotion of...

  • Regulatory Affairs Specialist

    vor 1 Woche

    Deutschland elemed Vollzeit

    Job Summary:We are seeking a highly experienced Global Regulatory Affairs Manager to join our team at Elemed. As a key member of our global regulatory team, you will be responsible for enabling and navigating product launches in various markets globally, with a focus on international markets.Key Responsibilities:Keep yourself and your colleagues up-to-date...

  • Regulatory Affairs Specialist

    vor 1 Woche

    Deutschland elemed Vollzeit

    Job Summary:We are seeking a highly experienced Global Regulatory Affairs Manager to join our team at Elemed. As a key member of our global regulatory team, you will be responsible for enabling and navigating product launches in various markets globally, with a focus on international markets.Key Responsibilities:Keep yourself and your colleagues up-to-date...

  • Regulatory Affairs Manager

    vor 1 Woche

    Deutschland JobGet Vollzeit

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at JobGet. As a key member of our organization, you will be responsible for preparing and submitting maintenance- and life-cycle activities for medicinal products, including variations, renewals, and PSUR submissions.Key ResponsibilitiesCoordinate projects, including...

  • Regulatory Affairs Manager

    Vor 6 Tagen

    Deutschland JobGet Vollzeit

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at JobGet. As a key member of our organization, you will be responsible for preparing and submitting maintenance- and life-cycle activities for medicinal products, including variations, renewals, and PSUR submissions.Key ResponsibilitiesCoordinate projects, including...

  • Global Regulatory Affairs Director

    Vor 5 Tagen

    Deutschland elemed Vollzeit

    About the RoleWe are seeking a highly experienced Global Regulatory Affairs Manager to join our team at Elemed, a leading MedTech technical recruiter. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring the company's medical devices comply with regulatory requirements globally.Key ResponsibilitiesStay up-to-date with the...

  • Global Regulatory Affairs Director

    Vor 6 Tagen

    Deutschland elemed Vollzeit

    About the RoleWe are seeking a highly experienced Global Regulatory Affairs Manager to join our team at Elemed, a leading MedTech technical recruiter. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring the company's medical devices comply with regulatory requirements globally.Key ResponsibilitiesStay up-to-date with the...

  • Regulatory Affairs Spezialist

    Vor 6 Tagen

    Deutschland JobGet Vollzeit

    Beschreibung des AufgabenbereichsSie arbeiten in einem renommierten Unternehmen mit einer erfolgreichen und etablierten Marktposition. Die Zusammenarbeit ist geprägt von Teamarbeit und einem produktiven Miteinander. Das Unternehmen bietet eine angenehme Arbeitsatmosphäre mit kollegialem Zusammenhalt.Abwechslung und HerausforderungenDas Aufgabengebiet ist...

  • Regulatory Affairs Spezialist

    Vor 7 Tagen

    Deutschland JobGet Vollzeit

    Beschreibung des AufgabenbereichsSie arbeiten in einem renommierten Unternehmen mit einer erfolgreichen und etablierten Marktposition. Die Zusammenarbeit ist geprägt von Teamarbeit und einem produktiven Miteinander. Das Unternehmen bietet eine angenehme Arbeitsatmosphäre mit kollegialem Zusammenhalt.Abwechslung und HerausforderungenDas Aufgabengebiet ist...

  • Global Regulatory Affairs Manager

    Vor 5 Tagen

    Deutschland elemed Vollzeit

    Job SummaryWe are seeking a highly experienced Global Regulatory Affairs Manager to join our team at Elemed. As a key member of our global regulatory team, you will be responsible for enabling and navigating product launches in various markets globally, with a focus on international markets.Key ResponsibilitiesKeep yourself and your colleagues up-to-date...

  • Global Regulatory Affairs Manager

    Vor 5 Tagen

    Deutschland elemed Vollzeit

    Job SummaryWe are seeking a highly experienced Global Regulatory Affairs Manager to join our team at Elemed. As a key member of our global regulatory team, you will be responsible for enabling and navigating product launches in various markets globally, with a focus on international markets.Key ResponsibilitiesKeep yourself and your colleagues up-to-date...

  • Regulatory Affairs Lead

    vor 1 Woche

    Deutschland elemed Vollzeit

    Job DescriptionJob Title: Global Regulatory Affairs ManagerJob Summary:We are seeking an experienced Global Regulatory Affairs Manager to join our team at Elemed. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for medical devices in various global markets.Key...

  • Regulatory Affairs Lead

    Vor 6 Tagen

    Deutschland X4 Life Sciences Vollzeit

    X4 Life Sciences is a rapidly expanding Pharmaceutical Service Provider in Germany seeking a highly skilled Regulatory Affairs Lead - Data Management to join their team.The successful candidate will be responsible for delivering high-quality services and driving business growth within data management. Key responsibilities include:Providing consultancy and...

  • Regulatory Affairs Lead

    Vor 7 Tagen

    Deutschland X4 Life Sciences Vollzeit

    X4 Life Sciences is a rapidly expanding Pharmaceutical Service Provider in Germany seeking a highly skilled Regulatory Affairs Lead - Data Management to join their team.The successful candidate will be responsible for delivering high-quality services and driving business growth within data management. Key responsibilities include:Providing consultancy and...

  • Global Regulatory Affairs Manager

    vor 1 Woche

    Deutschland elemed Vollzeit

    Job DescriptionJob Title: Global Regulatory Affairs ManagerJob Summary:We are seeking an experienced Global Regulatory Affairs Manager to join our team at Elemed. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for medical devices in various global markets.Key...

  • Regulatory Reporting Specialist

    Vor 6 Tagen

    Deutschland Objectway Vollzeit

    Job Title: Regulatory Reporting SpecialistJob Summary:We are seeking a highly skilled Regulatory Reporting Specialist to join our Consultant Team in Germany. As a key member of our team, you will be responsible for further developing our specialist module regulatory reporting/AWV of our overall banking system OBS.Key Responsibilities:Further development of...

  • Regulatory Reporting Specialist

    Vor 7 Tagen

    Deutschland Objectway Vollzeit

    Job Title: Regulatory Reporting SpecialistJob Summary:We are seeking a highly skilled Regulatory Reporting Specialist to join our Consultant Team in Germany. As a key member of our team, you will be responsible for further developing our specialist module regulatory reporting/AWV of our overall banking system OBS.Key Responsibilities:Further development of...