Technical Regulator for Medical Devices and Combination Products

5 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €142,000
Regulatory Specialist for Medical Devices and Combination Products

This is a challenging role that requires a strong understanding of global medical device and drug-device combination product regulatory requirements. The ideal candidate will have experience in pharmaceutical and/or medical device development, with a focus on technical regulatory strategy and content.

The successful applicant will be responsible for maintaining detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to the company's development programs. They will also collaborate with cross-functional teams to develop regulatory strategies for combination products and medical devices, and provide expert advice to the EU regulatory function in relation to device constituent of Drug Device Combination products.

In addition, the Regulatory Specialist will lead program teams in the implementation and execution of strategies and plans that ensure compliance to regulations, legislations, standards, and regulatory guidelines. They will also drive the authoring and review of documents for regulatory submissions, including New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Application (BLA), Marketing Authorisation Applications (MAAs), variations and other related activities.

For this role, we are looking for a candidate with a Bachelor's degree in a scientific/engineering discipline, preferably with a master's or higher degree. The ideal candidate will have proven experience in multi-disciplinary teams within a pharmaceutical development environment, with a significant proportion having a drug delivery/device focus. They should also have demonstrable track record of competence in leading device program teams in problem solving approaches to technical regulatory issues.

Benefits of working with us include competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others. We offer excellent career progression opportunities, work-life balance initiatives, bonus scheme, health insurance, pension, and more.

  • Medical Device and Combination Product Quality Leader

    4 days ago

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

    Job Title: Manager, Medical Device and Combination Product Quality SystemsThe successful candidate will lead the sustainment, improvement, and globalization of quality management systems in support of medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU...

  • Senior Medical Device Regulations Expert

    1 week ago

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

    Job OverviewThe primary role of the Regulatory Affairs Specialist is to manage post-market activities for medical devices. The specialist will support global regulatory processes and procedures, develop strategies, author documents, and collaborate with international registrations.Main Responsibilities:Develop regulatory strategies for overseas medical...

  • Technical Regulatory Specialist for Medical Devices

    2 days ago

    Dublin, Dublin City, Ireland beBeeMedical Full time €120,000 - €150,000

    Regulatory Specialist for Medical DevicesThis position requires a subject matter expert in the application of FDA, EU and ISO standards, regulations and guidance related to design control and regulatory compliance.The successful candidate will maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest...

  • 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,...

  • Medical Devices Regulatory Compliance Specialist

    2 weeks ago

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

    Job OverviewThis role is responsible for leading the technical regulatory compliance of medical devices and drug-device combination products. The successful candidate will have a strong understanding of FDA, EU, and ISO standards, regulations, and guidance related to design control and regulatory compliance.Key ResponsibilitiesMaintain awareness of current...

  • 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...

  • 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...

  • Senior Product Assurance Engineer for Combination Products

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeDeviceDevelopment Full time €122,127 - €132,619

    Job DescriptionThe Principal Device Development Assurance Scientist/Engineer will play a pivotal role in ensuring the design and development of combination products comply with design control requirements outlined in Quality Management Systems and relevant regulations.This position will be responsible for supporting device development programs through the...

  • Device Technical Regulatory Associate Specialist

    4 weeks ago

    Dublin, Dublin City, Ireland Viatris Full time

    Social network you want to login/join with:Device Technical Regulatory Associate Specialist, Dublincol-narrow-leftClient:ViatrisLocation:Dublin, IrelandJob Category:Other-EU work permit required:Yescol-narrow-rightJob Reference:07c2a9724d21Job Views:6Posted:19.08.2025Expiry Date:03.10.2025col-wideJob Description:At VIATRIS, we see healthcare not as it is but...

  • Medical Device Development Lead

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeDevelopment Full time €96,000 - €134,000

    Senior Medical Device Development ProfessionalThe successful candidate will lead the design, development, and performance evaluation of drug-device combination products.Provide subject matter expertise to support the development of Combination ProductsPlan and execute design verification and reliability strategiesBe the technical interface between drug...