Regulatory Compliance Specialist

Vor 6 Tagen

Deutschland BioTalent Vollzeit
Job Title: Senior Regulatory Specialist

Join BioTalent, a leading innovator in Medical Devices, as we seek a Senior Regulatory Specialist to lead our regulatory activities and ensure compliance with international regulations and standards.

About the Role

We are looking for a highly experienced Senior Regulatory Specialist with expertise in the Medical Device Regulation (MDR) and a strong understanding of Electromagnetic Compatibility (EMC) safety standards. As a key member of our team, you will oversee and manage the regulatory compliance process in accordance with the European Union Medical Device Regulation (MDR), ensuring products meet all legal requirements for safety and performance.

Key Responsibilities
  • Lead regulatory activities and ensure compliance with international regulations and standards.
  • Oversee and manage the regulatory compliance process in accordance with the European Union Medical Device Regulation (MDR).
  • Provide guidance and support on Electromagnetic Compatibility (EMC) standards and safety requirements.
  • Collaborate with cross-functional teams to ensure regulatory requirements are integrated into product design and development processes.
  • Prepare and maintain regulatory documentation, technical files, and submission dossiers for global market entry.
  • Stay up-to-date with global regulatory trends and changes, particularly in MDR and EMC.
  • Support internal audits and participate in external audits related to regulatory compliance and certifications.
  • Develop and deliver training on regulatory requirements and compliance processes.
Requirements
  • Previous experience within Medical Devices.
  • Experience of working across international markets.
  • Strong understanding of EMC safety regulations and how they apply to medical and industrial equipment.
  • Experience working with international regulatory bodies and submission processes.
  • Ability to work effectively in a fast-paced, dynamic environment and manage multiple projects simultaneously.
About BioTalent

BioTalent is a dynamic and collaborative environment with opportunities for professional development and growth. We are committed to innovation and excellence in Medical Devices, and we are seeking a talented Senior Regulatory Specialist to join our team.

  • Regulatory Compliance Expert

    vor 1 Woche

    Deutschland BioTalent Vollzeit

    Job Title: Regulatory Specialist and Senior SpecialistJoin BioTalent, a leading innovator in Medical Devices, as we seek a Senior Regulatory Specialist to lead our regulatory activities and ensure compliance with international regulations and standards.About the RoleWe are looking for a highly skilled and experienced professional to oversee and manage the...

  • Regulatory Compliance Expert

    vor 1 Woche

    Deutschland BioTalent Vollzeit

    Job Title: Regulatory Specialist and Senior SpecialistJoin BioTalent, a leading innovator in Medical Devices, as we seek a Senior Regulatory Specialist to lead our regulatory activities and ensure compliance with international regulations and standards.About the RoleWe are looking for a highly skilled and experienced professional to oversee and manage the...

  • Regulatory Compliance Specialist

    Vor 5 Tagen

    Deutschland Melio Life Science Vollzeit

    Department Head - Quality Management, Regulatory Affairs & Product DevelopmentWe are seeking a highly experienced Department Head to lead our Quality Management, Regulatory Affairs & Product Development department. As a key member of our team, you will be responsible for ensuring the highest standards of quality and regulatory compliance in our medical...

  • Regulatory Compliance Specialist

    Vor 5 Tagen

    Deutschland Melio Life Science Vollzeit

    Department Head - Quality Management, Regulatory Affairs & Product DevelopmentWe are seeking a highly experienced Department Head to lead our Quality Management, Regulatory Affairs & Product Development department. As a key member of our team, you will be responsible for ensuring the highest standards of quality and regulatory compliance in our medical...

  • Regulatory Compliance Specialist

    Vor 5 Tagen

    Deutschland Melio Life Science Vollzeit

    Lead Quality Management and Regulatory AffairsAs a key member of our team at Melio Life Science, you will be responsible for leading our Quality Management and Regulatory Affairs department. This is a unique opportunity to drive innovation and shape the future of medical device development.Key Responsibilities:Develop and implement risk management strategies...

  • Regulatory Compliance Specialist

    Vor 5 Tagen

    Deutschland Melio Life Science Vollzeit

    Lead Quality Management and Regulatory AffairsAs a key member of our team at Melio Life Science, you will be responsible for leading our Quality Management and Regulatory Affairs department. This is a unique opportunity to drive innovation and shape the future of medical device development.Key Responsibilities:Develop and implement risk management strategies...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    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 3 Wochen

    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 3 Wochen

    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 3 Wochen

    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 3 Wochen

    Deutschland Indegene Vollzeit

    About IndegeneWe 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,...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Deutschland Indegene Vollzeit

    About IndegeneWe 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,...

  • Regulatory Affairs Specialist

    Vor 5 Tagen

    Deutschland Indegene Vollzeit

    Join Indegene's Team as a Regulatory Affairs ConsultantWe are a technology-led healthcare solutions provider driven by our purpose to enable healthcare organizations to be future-ready. Our accelerated, global growth opportunities are ideal for talent that's bold, industrious, and nimble.As a rapidly growing global organization, we're scouting for the best...

  • Regulatory Affairs Specialist

    Vor 5 Tagen

    Deutschland Indegene Vollzeit

    Join Indegene's Team as a Regulatory Affairs ConsultantWe are a technology-led healthcare solutions provider driven by our purpose to enable healthcare organizations to be future-ready. Our accelerated, global growth opportunities are ideal for talent that's bold, industrious, and nimble.As a rapidly growing global organization, we're scouting for the best...

  • Regulatory Affairs Specialist

    Vor 5 Tagen

    Deutschland Indegene Vollzeit

    Join Indegene's Team as a Regulatory Affairs ConsultantWe are a technology-led healthcare solutions provider driven by our purpose to enable healthcare organizations to be future-ready. Our accelerated, global growth opportunities are ideal for talent that's bold, industrious, and nimble.As a rapidly growing global organization, we're scouting for the best...

  • Regulatory Affairs Specialist

    Vor 5 Tagen

    Deutschland Indegene Vollzeit

    Join Indegene's Team as a Regulatory Affairs ConsultantWe are a technology-led healthcare solutions provider driven by our purpose to enable healthcare organizations to be future-ready. Our accelerated, global growth opportunities are ideal for talent that's bold, industrious, and nimble.As a rapidly growing global organization, we're scouting for the best...

  • Regulatory Reporting Specialist

    vor 3 Wochen

    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 3 Wochen

    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 2 Wochen

    Deutschland Objectway Vollzeit

    Join Our Team as a Regulatory Reporting SpecialistWe 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 the...

  • Regulatory Reporting Specialist

    vor 2 Wochen

    Deutschland Objectway Vollzeit

    Join Our Team as a Regulatory Reporting SpecialistWe 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 the...