Regulatory Affairs Specialist

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  • Galway, Republic of Ireland

About the Company

A Global Healthcare technology leader company are looking for a Senior Regulatory Affairs Specialist to join their team on a 12-month Contract.

About your new job as a Senior Regulatory Affairs Specialist

  • Oversees or handles the organization and preparation of document packages for regulatory submissions.
  • Assists with change control activities to facilitate global approval and implementation of product and process modifications.
  • Leads or assembles all materials needed for submissions, license renewals, and annual registrations.
  • Collaborates with business unit Regulatory Affairs Specialists and international regulatory staff to provide regulatory support. Works alongside engineers and technical experts to create solid regulatory strategies and address inquiries from regulatory agencies.
  • Suggests updates for labeling and internal documentation to ensure regulatory compliance.
  • Stays informed about regulatory procedures and updates. Aids in the review of internal procedures to maintain continuous compliance with all regulatory requirements.
  • May directly interact with regulatory agencies on specific issues.
  • Supports regulatory compliance activities, including manufacturing site registration and GMP audits as necessary.
  • Identifies and promotes best practices within the Regulatory Affairs Department, including ongoing development initiatives.

What skill/experience you need as a Senior Regulatory Affairs Specialist

  • Bachelor Level 8 Honour’s Degree in Science or Engineering with at least 5 years of relevant experience, ideally with Class III devices. A Regulatory Affairs qualification is helpful but not required.
  • Have regulatory experience in Medical Devices, Pharmaceuticals, Medical Device Software, or a similar regulated industry.
  • A proactive team player
  • Strong technical knowledge, critical thinking, and decision-making skills.
  • Work well with global cross-functional teams and align team efforts.
  • Familiar with FDA regulations, EU MDR, Regulation (EU) 2017/745, and other international regulatory requirements.
  • Able to guide, coach, and train colleagues.
  • Set high standards, ensure accountability, and model ethical behaviour
  • Manage multiple projects and priorities effectively.
  • Detail-oriented and results-driven.
  • Strong problem-solving skills, able to identify risks and escalate issues when needed.

What’s on offer as a Senior Regulatory Affairs Specialist

  • 12 Month Contract
  • Salary DOE
  • 39 hour week
  • Obtain experience working with a Global healthcare technology leader

What’s next

  • Apply now by clicking “Apply Now” or contact me at 021 484 7135
  • Or if the job isn’t quite right but you are looking for something similar, please get in touch.


Apply for this role