Back to Job Search

Senior Regulatory Affairs Specialist

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 23714

Senior Regulatory Affairs Specialist MDR

Location: Galway

Contract Type: 12-Month Initial Contract


Company Overview:

Our client, a leading Galway-based multinational, is seeking a highly motivated Senior Regulatory Affairs Specialist with expertise in MDR (Medical Device Regulation) to join their team. This is an exciting opportunity to contribute to the development and compliance of innovative medical devices in a dynamic and collaborative environment.


Responsibilities:

  • Direct or coordinate the preparation and submission of document packages for regulatory submissions, internal audits, and inspections.

  • Lead or compile all materials required for submissions, license renewals, and annual registrations.

  • Recommend changes to labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance.

  • Monitor and improve tracking and control systems for regulatory activities.

  • Stay informed on regulatory procedures and updates to ensure ongoing compliance.

  • Act as the point of contact for interactions with regulatory agencies on defined matters.

  • Develop strategies to secure the earliest possible approvals for clinical trial applications.

Requirements:

  • Level 8 Honor’s Degree in Science or Engineering (Bachelor’s or Master’s degree).

  • A minimum of 5 years of relevant experience, preferably working with Class III medical devices.

  • Experience in regulatory roles within Medical Devices, Pharmaceuticals, or similar regulated industries.

  • Strong technical knowledge with the ability to critically assess and make sound decisions.

  • Proven understanding of engineering principles, physiology, and medical device applications.

  • Proficiency in collaborating with global cross-functional teams and fostering alignment.

  • In-depth knowledge of FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745, and international regulatory agency standards.

  • Capability to provide guidance, coaching, and training to colleagues within the job area.

  • Exceptional organisational skills with the ability to manage multiple projects and priorities effectively.

  • Excellent attention to detail, results-driven mindset, and ethical standards.

  • Demonstrated problem-solving skills and the ability to escalate issues appropriately.

Nice-to-Have:

  • Regulatory Affairs qualification (preferred but not mandatory).

  • Experience using AI in a regulatory environment.

For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717