Senior Regulatory Expert

2 weeks ago

Galway, Galway, Ireland beBeeRegulatory Full time €114,390 - €128,550
Job Function:

Regulatory Affairs

Sub Function:

Regulatory Product Submissions and Registration

We are seeking a highly skilled professional to lead our Regulatory Affairs Program in Galway, Ireland.

The 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 new/modified product launches and ongoing regulatory compliance.

  • Defines data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
  • Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products.
  • Clearly defines and prioritises decision criteria, considers the benefits and risks of each solution before making decisions.
  • Develops labelling specifications and approves proposed labelling and packaging, after evaluating conformance to regulations.
  • Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials.
  • Ensures compliance with regulatory agency regulations and interpretations.
  • Prepares responses to regulatory agencies' questions and other correspondence.
  • Provides regulatory advice to project teams.

This role requires experience in the medical device industry, knowledge of European Medical Device Directive/Regulation (EU MDD 93/42/EEC and EU MDR 2017/745), FDA's 21 CFR Part 812, 21 CFR Part 807, 21 CFR Part 814, and relevant European and US regulations and standards.

Key Requirements:

  • Medical device industry experience.
  • Knowledge of EU MDD 93/42/EEC and EU MDR 2017/745.
  • FDA's 21 CFR Part 812, 21 CFR Part 807, and 21 CFR Part 814.
  • Excellent interpersonal skills.
  • Written and communication skills.
  • Judgment/decision making.
  • Problem-solving ability.

About this role:

This is an exciting opportunity to join our team as Senior Regulatory Affairs Program Lead. As a key member of our Regulatory Affairs department, you will be responsible for providing strategic guidance and support to product development teams.

  • Senior Regulatory Affairs Expert

    1 day 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...

  • Senior Regulatory Compliance Manager

    2 weeks ago

    Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €125,000

    Job Title: Principal Regulatory Affairs SpecialistThis is a senior-level role within our regulatory affairs team, responsible for providing expert guidance and support to ensure compliance with regulatory requirements.Responsibilities:Develop and maintain positive relationships with device reviewers through oral and written communications regarding...

  • Regulatory Affairs Lead

    2 weeks ago

    Galway, Galway, Ireland beBeeRegulatory Full time €90,000 - €100,000

    Regulatory Affairs Lead">">We are seeking a skilled Regulatory Affairs professional to lead our regulatory strategy in Galway, Ireland.">As Senior Regulatory Affairs Program Lead, you will provide expert guidance on International pre-marketing applications and support optimal timelines for new/modified product launches.">Key responsibilities include...

  • Senior Regulatory Affairs Professional

    2 weeks ago

    Galway, Galway, Ireland beBeeRegulatory Full time €80,000 - €110,000

    Job Role: Senior Regulatory Affairs SpecialistJob DescriptionThe ideal candidate will play a key role in the implementation of post-market activities, ensuring compliance with relevant Quality System procedures and Work Instructions.This position involves coordinating the approval of Vigilance/MDR reporting as defined in each territory, supporting and...

  • Medical Device Regulatory Expert

    2 weeks ago

    Galway, Galway, Ireland beBeeRegulatory Full time €100,000 - €140,000

    Regulatory Affairs Manager Job DescriptionWe are seeking a highly motivated and experienced Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.The successful candidate will be...

  • 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:...

  • 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

    4 hours 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

    2 weeks 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...

  • Regulatory Affairs Lead

    2 weeks ago

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

    Senior Regulatory Affairs ProfessionalWe are seeking a Senior Regulatory Affairs Specialist to lead our regulatory activities including product certification and compliance.The successful candidate will be responsible for managing the regulatory and vigilance process, preparing regulatory submissions for required markets, and maintaining technical files for...