Regulatory Affairs Professional

20 hours 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 Description

As a Regulatory Affairs Manager, you will play a critical role in defining and executing regulatory strategies that support both new product development and post-market activities. You will work closely with cross-functional teams to ensure seamless execution of regulatory initiatives.

Key Responsibilities:
  • Develop and implement regulatory strategies for new product introductions and existing products.
  • Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations.
  • Act as the primary point of contact for regulatory agencies, including authorities in the U.S. and Europe.
  • Monitor and interpret evolving regulatory requirements to ensure company compliance.
  • Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
  • Review and approve promotional and advertising materials from a regulatory perspective.
  • Identify and allocate internal and external resources needed to maintain a robust regulatory function.
  • Provide strategic advice and cross-functional support on all regulatory matters.
Requirements

To succeed in this role, you must have a Bachelor's degree in Engineering, Life Sciences, or a health-related field. A minimum of 10+ years of experience in the medical device industry, with at least 3 years in a leadership or management role is required.

Preferred Qualifications
  • In-depth knowledge of US FDA and EU medical device regulations, including MDR.
  • Proven ability to handle complex regulatory submissions and interactions.
  • Excellent organizational, leadership, and communication skills.
  • A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment.
  • Previous experience in an SME or medtech startup is highly desirable.
Contact Information

For further information, please contact James Cassidy or call 086 0204322.

  • Senior Regulatory Affairs Professional

    2 days ago

    Galway, Galway, Ireland beBeeRegulatory Full time €100,000 - €130,000

    We are seeking a highly skilled Senior Regulatory Affairs Professional to lead our regulatory affairs program in Galway, Ireland.Job DescriptionThe successful candidate will provide independent regulatory guidance to product development teams on International pre-marketing applications, and any related submissions to support optimal timelines for...

  • Senior Regulatory Affairs Expert

    4 days ago

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

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory department, you will play a critical role in ensuring that our medical devices comply with all relevant regulations and guidelines.The successful candidate will have a strong understanding of global medical device...

  • Graduate Regulatory Affairs Specialist

    3 weeks ago

    Galway, Galway, Ireland Veryan Medical Full time

    Join to apply for the Graduate Regulatory Affairs Specialist role at Veryan MedicalJoin to apply for the Graduate Regulatory Affairs Specialist role at Veryan MedicalGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Veryan MedicalHR Coordinator, Veryan Medical | Assoc CIPD | MSc HRMGraduate Opportunity:...

  • Principal Regulatory Affairs Specialist

    2 weeks ago

    Galway, Galway, Ireland Boston Scientific Full time

    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training,...

  • Principal Regulatory Affairs Specialist

    2 weeks ago

    Galway, Galway, Ireland Boston Scientific Full time

    Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges.With access to the latest tools, information and training,...

  • Graduate Regulatory Affairs Specialist

    3 weeks ago

    Galway, Galway, Ireland Veryan Medical Full time

    Graduate Opportunity: Regulatory Affairs SpecialistFull time- Fixed Term (Maternity Contract)Galway- HybridAre you a recent graduate eager to kick-start your career in the medical device industry? Do you want to make a real impact in healthcare innovation while growing professionally in a supportive, dynamic environment?As a Graduate Regulatory Affairs...

  • Graduate Regulatory Affairs Specialist

    4 weeks ago

    Galway, Galway, Ireland Veryanmed Full time

    Graduate Opportunity: Regulatory Affairs SpecialistFull time- Fixed Term (Maternity Contract)Galway- HybridAre you a recent graduate eager to kick-start your career in the medical device industry? Do you want to make a real impact in healthcare innovation while growing professionally in a supportive, dynamic environment?As a Graduate Regulatory Affairs...

  • Regulatory Affairs Expert

    2 days ago

    Galway, Galway, Ireland beBeeCompliance Full time €80,000 - €120,000

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Expert to join our organization.Key ResponsibilitiesDevelop and implement regulatory strategies to obtain and maintain regulatory approval for medical devices in target markets.Lead design reviews in compliance with internal procedures and EU and FDA requirements, including maintaining design...

  • Senior Regulatory Affairs Program Lead

    1 week ago

    Galway, Galway, Ireland Johnson & Johnson Full time

    At Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...

  • Senior Regulatory Affairs Program Lead

    3 days ago

    Galway, Galway, Ireland Johnson & Johnson Full time

    At Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...