Regulatory Affairs Specialist

Vor 6 Tagen

Stuttgart, Baden-Württemberg, Deutschland Indegene Vollzeit
About the Role

Indegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for providing expert regulatory advice to our team and ensuring that our clients' projects meet regulatory requirements.

Key Responsibilities
  • Provide guidance on standards pertaining to advertising and promotion of medical devices in Germany and the EU.
  • Provide guidance on Germany Regulatory Requirements for promotional material review for medical devices.
  • Provide guidance on review workflow for medical device promotional materials for the German market.
  • Provide 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.
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 analyse complex regulatory issues, propose effective solutions, and make sound recommendations to stakeholders.
About Indegene

Indegene is a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration, and empathy.

  • Senior Regulatory Affairs Specialist

    Vor 4 Tagen

    Stuttgart, Baden-Württemberg, Deutschland BASF Services Europe GmbH Vollzeit

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our Agricultural Solutions Expert Services Team at BASF Services Europe GmbH.Key ResponsibilitiesUnder the guidance of experienced colleagues, you will be introduced to the global regulatory environment for crop protection products and develop a solid understanding of major...

  • Senior Regulatory Affairs Specialist

    Vor 4 Tagen

    Stuttgart, Baden-Württemberg, Deutschland BASF Services Europe GmbH Vollzeit

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our Agricultural Solutions Expert Services Team at BASF Services Europe GmbH.Key ResponsibilitiesUnder the guidance of experienced colleagues, you will be introduced to the global regulatory environment for crop protection products and develop a solid understanding of major...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Stuttgart, Baden-Württemberg, Deutschland EPM Scientific Vollzeit

    Job Summary:EPM Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with national and international regulatory requirements for medical devices.Key Responsibilities:Regulatory Documentation: Create and update 510(k) regulatory...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Stuttgart, Baden-Württemberg, Deutschland EPM Scientific Vollzeit

    Job Summary:EPM Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with national and international regulatory requirements for medical devices.Key Responsibilities:Regulatory Documentation: Create and update 510(k) regulatory...

  • Regulatory Affairs Manager

    vor 5 Stunden

    Stuttgart, Baden-Württemberg, Deutschland Sanero Medical GmbH Vollzeit

    AufgabenAls Regulatory Affairs Manager bei Sanero Medical GmbH bist du verantwortlich für die Umsetzung der regulatorischen Anforderungen unserer medizinischen Apps. Du begleitest das Konformitätsbewertungsverfahren für Klasse 1 und 2a und verantwortest die QM-Dokumentation sowie die Technische Dokumentation. Du betreust Aktivitäten zur Aufrechterhaltung...

  • Regulatory Affairs Manager

    vor 5 Stunden

    Stuttgart, Baden-Württemberg, Deutschland Sanero Medical GmbH Vollzeit

    AufgabenAls Regulatory Affairs Manager bei Sanero Medical GmbH bist du verantwortlich für die Umsetzung der regulatorischen Anforderungen unserer medizinischen Apps. Du begleitest das Konformitätsbewertungsverfahren für Klasse 1 und 2a und verantwortest die QM-Dokumentation sowie die Technische Dokumentation. Du betreust Aktivitäten zur Aufrechterhaltung...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Stuttgart, Baden-Württemberg, Deutschland EPM Scientific Vollzeit

    Job Summary:EPM Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with national and international regulatory requirements for medical devices.Key Responsibilities:Regulatory Documentation: Create and update 510(k) regulatory documentation...

  • Regulatory Affairs Specialist

    Vor 6 Tagen

    Stuttgart, Baden-Württemberg, Deutschland EPM Scientific Vollzeit

    Job Summary:EPM Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance with national and international regulatory requirements for medical devices.Key Responsibilities:Regulatory Documentation: Create and update 510(k) regulatory documentation...

  • Regulatory Affairs Lead

    Vor 6 Tagen

    Stuttgart, Baden-Württemberg, Deutschland X4 Life Sciences Vollzeit

    X4 Life Sciences is a rapidly expanding Pharmaceutical Service Provider in Germany seeking a Regulatory Affairs Lead - Data Management to grow their team.The Regulatory Affairs Lead will be responsible for delivering high-quality services and being at the forefront of the business within data management.A strong background in Aris Global, Veeva, and IDMP is...

  • Regulatory Affairs Lead

    Vor 6 Tagen

    Stuttgart, Baden-Württemberg, Deutschland X4 Life Sciences Vollzeit

    X4 Life Sciences is a rapidly expanding Pharmaceutical Service Provider in Germany seeking a Regulatory Affairs Lead - Data Management to grow their team.The Regulatory Affairs Lead will be responsible for delivering high-quality services and being at the forefront of the business within data management.A strong background in Aris Global, Veeva, and IDMP is...

  • Global Regulatory Affairs Manager

    Vor 6 Tagen

    Stuttgart, Baden-Württemberg, Deutschland elemed Vollzeit

    Job DescriptionJob Title: Global Regulatory Affairs ManagerJob Type: Full-timeCompany: ElemedLocation: RemoteAbout Us: Elemed is a leading MedTech technical recruiter specializing in the Medical device, diagnostic, and combination device arena. We help medical device experts become leaders of tomorrow.Job Summary: We are seeking an experienced Global...

  • Global Regulatory Affairs Manager

    Vor 6 Tagen

    Stuttgart, Baden-Württemberg, Deutschland elemed Vollzeit

    Job DescriptionJob Title: Global Regulatory Affairs ManagerJob Type: Full-timeCompany: ElemedLocation: RemoteAbout Us: Elemed is a leading MedTech technical recruiter specializing in the Medical device, diagnostic, and combination device arena. We help medical device experts become leaders of tomorrow.Job Summary: We are seeking an experienced Global...

  • Regulatory Affairs Specialist in Food Safety

    vor 4 Wochen

    Stuttgart, Baden-Württemberg, Deutschland Tetra Pak Vollzeit

    Tetra Pak Food Packaging Safety & InteractionPosition: Food Contact Regulatory Compliance ExpertRole Overview: As a key player in our team, you will be responsible for ensuring adherence to food contact materials legislation across various regions including Europe, the United States, and China. Your expertise will support both development initiatives and...

  • Regulatory Reporting Specialist

    Vor 4 Tagen

    Stuttgart, Baden-Württemberg, Deutschland Objectway Vollzeit

    We are seeking a highly skilled Regulatory Reporting Specialist to join our team at Objectway. As a key member of our Consultant Team, you will be responsible for further developing our specialist module regulatory reporting/AWV of our overall banking system OBS.Key Responsibilities:Develop and maintain our regulatory reporting module to ensure compliance...

  • Regulatory Reporting Specialist

    Vor 4 Tagen

    Stuttgart, Baden-Württemberg, Deutschland Objectway Vollzeit

    We are seeking a highly skilled Regulatory Reporting Specialist to join our team at Objectway. As a key member of our Consultant Team, you will be responsible for further developing our specialist module regulatory reporting/AWV of our overall banking system OBS.Key Responsibilities:Develop and maintain our regulatory reporting module to ensure compliance...

  • Regulatory Reporting Specialist

    vor 4 Wochen

    Stuttgart, Baden-Württemberg, Deutschland Creditplus Bank AG Vollzeit

    Regulatory Reporting Specialist (m/w/d) bei Creditplus Bank AG | softgardenRegulatory Reporting Specialist (m/w/d)VollzeitHybridMit BerufserfahrungEUR 56500, ,00Über unsWir sind darauf spezialisiert, die Wünsche unserer Kund:innen zu erfüllen und ihre Träume mit unseren Finanzlösungen zu realisieren. Als innovative Institution sehen wir uns nicht als...

  • Regulatory Reporting Specialist

    vor 4 Wochen

    Stuttgart, Baden-Württemberg, Deutschland Creditplus Bank AG Vollzeit

    Regulatory Reporting Specialist (m/w/d) bei Creditplus Bank AG | softgardenRegulatory Reporting Specialist (m/w/d)VollzeitHybridMit BerufserfahrungEUR 56500, ,00Über unsWir sind darauf spezialisiert, die Wünsche unserer Kund:innen zu erfüllen – unsere Mission ist es, das Leben unserer Kund:innen zu bereichern und ihre finanziellen Träume zu...

  • Senior Regulatory Affairs Officer

    vor 3 Wochen

    Stuttgart, Baden-Württemberg, Deutschland PIMCO Prime Real Estate GmbH Vollzeit

    Position Overview:The Senior Compliance Officer (m/f/d) for Anti-Financial Crime at PIMCO Prime Real Estate GmbH is tasked with assisting the global Chief Compliance Officer in navigating compliance and regulatory challenges, particularly in the realm of anti-financial crime, which encompasses anti-money laundering, bribery and corruption, and...

  • Student Assistant in Regulatory Insurance Affairs

    vor 4 Wochen

    Stuttgart, Baden-Württemberg, Deutschland Mercedes-Benz Vollzeit

    Position Overview: Join the Mercedes-Benz Insurance Services team as a working student in the Insurance Governance area. This role offers a unique opportunity to contribute to the implementation of regulatory standards and corporate guidelines within our insurance entities. Key Responsibilities: Assist in qualitative risk management initiatives. Support the...

  • Regulatory Compliance Specialist

    Vor 6 Tagen

    Stuttgart, Baden-Württemberg, Deutschland Scienta Vollzeit

    **Meet Our Customers and Partners**We are looking for a skilled Regulatory Expert to join our team at Scienta. As a key member of our organization, you will be responsible for building and maintaining strong relationships with our customers and partners.**Regular Meetings and Communication**You will meet with our customers and partners regularly, both in...