Regulatory Affairs Specialist II

9 hours ago

Loch Garman, Loch Garman, Ireland STRIVE Search Full time
Overview

Regulatory Affairs Specialist - II — Co. Wexford, Hybrid

Globally renowned MedTech expansion following EU funding for R&D Centre of Excellence

Background

Our client is in search of a Regulatory Affairs Specialist - II to lead projects in new product development with experience in an IVDR or Med Device ISO13485 regulated environment.

What's on offer?
  • Lucrative package with pension, healthcare and more
  • Opportunity to work with experts in the field in a non-political work culture environment
  • Clear career progression opportunities internally
Key Responsibilities
  • Lead projects for new product development projects, providing advice to development teams
  • Provide regulatory guidance on changes to existing products
  • Provide regulatory input to support post-market surveillance and vigilance activities
  • Act as Subject Matter Expert within 3rd party and internal audits
Key Requirements
  • Regulatory Affairs experience in the In Vitro Diagnostic or Medical Device environment.
  • Knowledge and application of 21 CFR 820 and ISO 13485 is required.
  • Experience with preparation and execution of regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval.

#J-18808-Ljbffr

  • Design Quality Engineer

    17 hours ago

    Loch Garman, Loch Garman, Ireland Cpl Full time

    Design Quality Engineer II — Enniscorthy, Co.Wexford.Type: Permanent, Full time.Our client, a global leader in medical technology, is seeking a Design Quality Engineer II to join their expanding team in Enniscorthy.This role is ideal for someone with a risk assessment and design quality mindset, who can challenge design processes and ensure products meet...

  • Design Quality Engineer New

    2 weeks ago

    Loch Garman, Loch Garman, Ireland CPL Full time

    Design Quality Engineer IILocation: Enniscorthy, Co. WexfordType: Permanent, Full timeOur client, a global leader in medical technology, is seeking a Design Quality Engineer II to join their expanding team in Enniscorthy. This role is ideal for someone with a risk assessment and design quality mindset, who can challenge design processes and ensure products...

  • Design Quality Engineer New

    1 week ago

    Loch Garman, Loch Garman, Ireland CPL Full time

    Design Quality Engineer IILocation: Enniscorthy, Co. WexfordType: Permanent, Full timeOur client, a global leader in medical technology, is seeking a Design Quality Engineer II to join their expanding team in Enniscorthy. This role is ideal for someone with a risk assessment and design quality mindset, who can challenge design processes and ensure products...

  • Design Quality Engineer

    1 week ago

    Loch Garman, Loch Garman, Ireland Cpl Full time

    Design Quality Engineer II — Enniscorthy, Co. Wexford. Type: Permanent, Full time. Our client, a global leader in medical technology, is seeking a Design Quality Engineer II to join their expanding team in Enniscorthy. This role is ideal for someone with a risk assessment and design quality mindset, who can challenge design processes and ensure products...

  • Design Quality Engineer

    2 weeks ago

    Loch Garman, Loch Garman, Ireland Cpl Full time

    OverviewDesign Quality Engineer II — Enniscorthy, Co. Wexford (Permanent, Full time)Our client, a global leader in medical technology, is seeking a Design Quality Engineer II to join their expanding team in Enniscorthy. This role suits someone with a risk assessment and design quality mindset who can challenge design processes and ensure products meet the...

  • Design Quality Engineer

    2 weeks ago

    Loch Garman, Loch Garman, Ireland Cpl Full time

    Design Quality Engineer IILocation: Enniscorthy, Co. WexfordType: Permanent, Full time Our client, a global leader in medical technology, is seeking a Design Quality Engineer II to join their expanding team in Enniscorthy. This role is ideal for someone with a risk assessment and design quality mindset, who can challenge design processes and ensure products...

  • Design Quality Specialist

    2 weeks ago

    Loch Garman, Loch Garman, Ireland beBeeQuality Full time €60,000 - €80,000

    About This RoleWe are seeking a skilled Design Quality Engineer to join our team. In this role, you will be responsible for ensuring the highest quality standards are met in product design.Key Responsibilities:Lead risk assessments on new devices using FMEA tools.Work closely with design, manufacturing, regulatory affairs, and compliance teams.Review design...

  • Senior Product Reliability Specialist

    2 weeks ago

    Loch Garman, Loch Garman, Ireland beBeeQuality Full time €80,000 - €100,000

    Job Title: Design Quality EngineerJob DescriptionThis role involves working closely with design, manufacturing, regulatory affairs and compliance teams. The successful candidate will be responsible for leading risk assessments on new devices using FMEA tools to stress-test designs.They will provide quality support across R&D, design, validation and test...

  • EIAR Specialist Lead

    1 week ago

    Loch Garman, Loch Garman, Ireland beBeeEnvironmental Full time €63,000 - €98,000

    EIAR Specialist Role Our organization seeks an experienced EIAR specialist to lead environmental impact assessments and prepare detailed reports. The ideal candidate will excel in conducting Environmental Impact Assessments (EIAs) and preparing comprehensive reports related to noise, air quality, water resources, and pre-planning permissions.Key...

  • Senior Quality Engineer

    7 days ago

    Loch Garman, Loch Garman, Ireland beBeeQuality Full time €70,000 - €85,000

    Product Design Assurance ProfessionalThis role is ideal for someone with a meticulous approach to quality, who can scrutinize product designs and ensure they meet the highest standards.Key Responsibilities:Collaborate closely with cross-functional teams, including design, manufacturing, regulatory affairs, and compliance.Lead thorough risk assessments on new...