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    • Previous experience within a regulated industry, ideally medical devices, pharmaceuticals, or healthcare.
    • Our client, a growing organisation operating within…
    • The Regulatory Affairs Specialist supports regulatory compliance activities across the product lifecycle, ensuring products meet regulatory requirements and…
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Job Post Details

Regulatory Affairs Specialist - job post

Hartley People
Dungarvan, County Waterford
Permanent, Full-time

Job details

Job type

  • Permanent
  • Full-time

Location

Dungarvan, County Waterford

Full job description

Hartley People Recruitment in partnership with our client are hiring for a Regulatory Affairs Specialist in Dungarvan, Co. Waterford.

About the Role

Our client, a growing organisation operating within the medical device and healthcare sector, is seeking a Regulatory Affairs Specialist to join their team. This position offers an excellent opportunity for a regulatory professional looking to develop their career within a highly regulated, international environment.

Reporting to senior leadership, the successful candidate will support regulatory compliance activities across multiple markets, ensuring products and processes meet applicable regulatory requirements and industry standards.

Key Responsibilities

  • Support regulatory compliance activities across EU and international markets.
  • Assist in maintaining regulatory documentation and technical files.
  • Support product registrations, regulatory submissions, and customer requirements.
  • Monitor changes to regulatory standards and communicate their impact across the business.
  • Assist with customer and regulatory audits as required.
  • Work closely with quality, operations, and manufacturing teams to ensure ongoing compliance.
  • Participate in risk management and change control activities.
  • Support the maintenance of quality management systems in line with applicable standards.
  • Contribute to continuous improvement initiatives within the regulatory function.
  • Build strong relationships with internal and external stakeholders.

Skills & Experience

  • Degree qualification in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related discipline.
  • Previous experience within a regulated industry, ideally medical devices, pharmaceuticals, or healthcare.
  • Understanding of regulatory requirements such as EU MDR, ISO 13485, FDA regulations, or similar standards would be advantageous.
  • Strong attention to detail and organisational skills.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Strong problem-solving and analytical abilities.
  • A proactive and collaborative approach to work.

For immediate consideration, please email your CV to darren@hartleypeople.com or call Darren on 051 878813.

Hartley People Recruitment works to the highest ethical standards in our industry. We value the trust you place in us when you send your CV. We guarantee that your CV will not be sent to any of our clients without your prior consent and are happy to provide a full, confidential consultation.

Work Location: In person

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