Regulatory Affairs Professional

6 days ago

Galway, Galway, Ireland beBeeRegulation Full time €90,000 - €120,000
Job Description:

We are seeking a highly skilled Regulatory Affairs professional to develop and lead the regulatory strategy for new product introductions and existing products throughout their lifecycle.

The ideal candidate will possess a strong background in medical device regulations, excellent organizational and leadership skills, and experience working in a dynamic environment.

This role requires a self-starter with a hands-on approach and the ability to thrive in a fast-paced environment.

Responsibilities:
  • Develop and implement global regulatory submissions, including 510(k) and CE Mark, to ensure compliance with evolving regulatory requirements.
  • Act as primary contact for regulatory agencies in the U.S. and Europe, providing strategic advice and support on all regulatory matters.
  • Partner with Quality Assurance to maintain post-market surveillance and vigilance activities in line with applicable standards.
Requirements:
  • Bachelor's degree in Engineering, Life Sciences, or a health-related field.
  • 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
  • Deep knowledge of US FDA and EU medical device regulations (including MDR).
  • Proven ability to handle complex regulatory submissions and interactions.
  • Excellent communication and leadership skills.
Preferred Qualifications:
  • Previous experience in an SME or medtech startup.

  • Regulatory Affairs Professional

    9 hours ago

    Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €130,000

    We are seeking a Regulatory Affairs Specialist to join our team. This role will provide strategic leadership and direction for regulatory affairs across product development process, submissions and regulatory compliance.Job DescriptionThis position will be responsible for providing positive relationships with device reviewers through oral and written...

  • Regulatory Affairs Professional

    2 weeks ago

    Galway, Galway, Ireland beBeeRegulatory Full time €85,000 - €105,000

    Our ideal candidate will be a strategic leader with expertise in regulatory affairs, overseeing the development and implementation of regulatory strategies to ensure compliance with all applicable laws and regulations.Job DescriptionAs a Regulatory Affairs Manager, you will play a critical role in defining and executing regulatory strategies that support...

  • Regulatory Affairs Specialist

    5 days ago

    Galway, Galway, Ireland beBeeRegulatory Full time €100,000 - €120,000

    Regulatory Affairs Specialist RoleWe are seeking an experienced Regulatory Affairs Specialist to join our team. As a key member of the Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key Responsibilities:Develop and maintain positive relationships with regulatory reviewers through...

  • Regulatory Affairs Expert

    1 week ago

    Galway, Galway, Ireland beBeeRegulatory Full time €60,000 - €80,000

    Senior Regulatory Affairs SpecialistThis role offers a fantastic opportunity to utilize your expertise in regulatory affairs and design assurance to contribute to the success of our company.We are seeking an experienced Senior Regulatory Affairs Specialist with a strong background in medical device regulations, specifically FDA guidance & MDD 93/42/EEC. As a...

  • Regulatory Affairs Strategist

    2 days ago

    Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €120,000 - €150,000

    Job OverviewWe are seeking a highly motivated Regulatory Affairs Strategist to lead and oversee all regulatory compliance activities.Key Responsibilities:Develop and execute regulatory strategies for new product introductions and post-market activities.Manage global product registrations and ensure compliance with evolving regulatory requirements.Serve as...

  • Regulatory Affairs Strategist

    2 weeks ago

    Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €60,000 - €80,000

    Job OverviewWe are seeking a Senior Regulatory Affairs Specialist to join our team.Required Skills and QualificationsThe ideal candidate will have:Maintain an excellent understanding of global medical device regulations, primarily in accordance with specific guidance & MDD 93/42 EEC.Develop global regulatory strategies for the company in collaboration with...

  • Regulatory Affairs Specialist

    1 day ago

    Galway, Galway, Ireland Medtronic plc Full time

    Regulatory Affairs Specialist page is loaded## Regulatory Affairs Specialistremote type: Hybridlocations: Galway, County Galway, Irelandtime type: Full timeposted on: Posted Todaytime left to apply: End Date: September 26, 2025 (10 days left to apply)job requisition id: R41370At Medtronic you can begin a life-long career of exploration and...

  • Senior Regulatory Affairs Expert

    3 days ago

    Galway, Galway, Ireland beBeeRegulatory Full time €70,000 - €95,000

    Regulatory Affairs ProfessionalWe are seeking a skilled Regulatory Affairs Specialist to manage regulatory and vigilance processes, prepare regulatory submissions, and maintain technical files.Key Responsibilities:Coordinate regulatory processes and ensure compliance with relevant regulations.Prepare and submit regulatory documents for product clearances and...

  • Regulatory Affairs Compliance Specialist

    19 hours ago

    Galway, Galway, Ireland beBeeRegulatoryAffairs Full time €90,000 - €120,000

    Our company is seeking a highly skilled Regulatory Affairs Specialist to ensure compliance with global regulatory requirements for medical devices.We require the successful candidate to develop and maintain positive relationships with device reviewers through oral and written communications, assist with policy implementation, provide Regulatory Affairs...

  • Principal Regulatory Affairs Specialist

    4 days ago

    Galway, Galway, Ireland Boston Scientific Gruppe Full time

    OverviewBoston Scientific is seeking aPrincipal Regulatory Affairs Specialiston a permanent basis to join our team.This role can be based out of either of the following Irish sites:Ireland-Galway; Ireland-Cork.Job PurposeResponsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance.Key...