Medical Device Regulatory Affairs Professional

3 days ago

Dublin, Dublin City, Ireland beBeeRegulatoryAffairsSpecialist Full time €80,000 - €120,000

Job Description:

">

We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The successful candidate will play an active role in developing the regulatory strategy for our medical devices in Europe and the US, while ensuring compliance with relevant regulations and standards.

">

Key Responsibilities:

">
  • ">
  • Support the creation and maintenance of product design and technical documentation in accordance with ISO 13485 and applicable regulations;">
  • Develop and submit high-quality clinical and regulatory files to ethical committees and regulatory agencies for successful approval;">
  • Organise and maintain regulatory submissions with authorities, committees, and investigation sites;">
  • Co-ordinate gap assessment activities and stay up-to-date with changes in applicable regulations and standards;">
  • Assist in preparing for inspections by notified bodies and regulatory authorities, and implement and maintain a robust quality system;">
  • Coordinate Adverse Event reporting and administer processes for product information control;">
">

Requirements:

">

To be successful in this role, you will require a Bachelor's degree in science or engineering, a proven track record in a similar role, and extensive knowledge of quality management systems, design controls, and current regulations. Prior experience in class III medical products and leadership/project management skills are highly desirable.

">

About the Opportunity:

">

This is an exciting opportunity to join a dynamic company developing innovative medical devices. As a key member of the team, you will have the chance to contribute to the development of our regulatory strategy and ensure the successful launch of our products.

"] ,

  • Medical Device Regulatory Affairs Professional

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €120,000

    Regulatory Affairs Specialist RoleThe position of Regulatory Affairs Specialist is responsible for overseeing post-market activities for medical devices, supporting regulatory processes and procedures, authoring and reviewing regulatory documentation, and ensuring timely and high-quality execution of all deliverables.Key Responsibilities:Develop and...

  • Regulatory Affairs Professional

    1 week ago

    Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €90,000 - €121,000

    Regulatory Affairs Specialist Job DescriptionThis is a key role in our organization, responsible for post-market activities for Administration and Safety System medical devices. We are seeking an experienced Regulatory Affairs Specialist to join our team.Job Summary:The successful candidate will be responsible for performing post-market surveillance...

  • Regulatory Affairs Professional

    2 days ago

    Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €70,000 - €95,000

    Job Title: Regulatory Affairs SpecialistDescription:The Senior Specialist, Regulatory Affairs position is responsible for overseeing post-market activities for medical devices and supporting departmental regulatory processes and procedures. This role also involves mentoring team members to ensure seamless execution of tasks.Key Responsibilities:Develop and...

  • Regulatory Affairs Professional

    1 week ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €100,000

    Regulatory Affairs Professional Role OverviewThis is a key role in the development of cutting-edge structural heart devices, working closely with cross-functional teams to ensure compliance with internal and external regulatory requirements.Key Responsibilities:Clinical:Coordinate and support global clinical trial execution, including site activation,...

  • Medical Device Regulatory Strategist

    1 week ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €120,000

    Regulatory Affairs ExpertiseThe Senior Specialist in Regulatory Affairs is responsible for post-market activities for medical devices, supporting departmental regulatory processes and procedures. Main Responsibilities:Develop and execute regulatory strategies for OUS medical devices and combination products.Create regulatory documentation such as CIAs,...

  • Regulatory Affairs Specialist

    6 days ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €100,000

    Regulatory Affairs ProfessionalThe ideal candidate will have a strong background in regulatory affairs, specifically in medical devices.Main Responsibilities:Develop and implement regulatory strategies to ensure compliance with European and US regulations.Support the creation and maintenance of product design and technical documentation in accordance with...

  • Medical Device Regulatory Specialist

    1 week ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time €118,500 - €143,000

    Job SummaryThe role of Regulatory Affairs Specialist is crucial for the post-market activities of medical devices, supporting departmental regulatory processes and procedures, strategies, authoring, reviewing, and supporting global registrations.Main Responsibilities:Support regulatory strategies for OUS medical devices and combination products, ensuring...

  • Regulatory Affairs Expert

    4 days ago

    Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €75,000 - €95,000

    Job Title: Regulatory Affairs ExpertWe are seeking a highly skilled Regulatory Affairs Expert to join our team. As a key member of our regulatory affairs group, you will play a critical role in ensuring that our medical devices comply with all relevant regulations and standards.About the RoleThis is an exciting opportunity to work with a leading medical...

  • Medical Device Compliance Professional

    1 week ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €110,000

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to fill a key role in our organization. The successful candidate will be responsible for post-market activities for medical devices, supporting departmental regulatory processes and procedures, and ensuring compliance with global regulations.Key...

  • Global Medical Device Regulatory Expert

    1 day ago

    Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €120,000

    Senior Regulatory Affairs SpecialistAs a Senior Regulatory Affairs Specialist, you will be responsible for leading post-market activities for Administration and Safety System medical devices.Key Responsibilities:Complete global Post Market Surveillance (PMS) activities and assignments for Administration and Safety System medical devices in West's...