Regulatory Affairs Specialist

4 days ago

Dublin, Dublin City, Ireland TN Ireland Full time

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Regulatory Affairs Specialist, Westmeath

Client: Critical Healthcare

Location: Westmeath, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference: 6db5ec06c42a

Job Views: 120

Posted: 21.01.2025

Expiry Date: 07.03.2025

Job Description:

We have a new opening for a Regulatory Affairs Specialist to join a well-established but rapidly growing international healthcare business based in Tullamore, Co Offaly. It is a great chance to be part of an organization that makes a real impact on millions of lives. The company has a significant presence in Ireland, the UK, and mainland Europe. This is a permanent position.

Key Responsibilities:

  • Identify products compliant or not with regulatory requirements in our current markets and liaise with non-compliant potential suppliers.
  • Research alternative EU based suppliers, improving our supply chain capability.
  • Evaluate and authorize if appropriate, changes to the manufacturing and supply chain processes.
  • Approve product labels, package inserts, and marketing material.
  • Create and maintain audit-friendly product files for customers and HPRA assurance.
  • A key element to our expansion will be the certification of ISO 27001.

The Person:

  • A minimum of 3-5 years' experience in a medical device/healthcare industry in a regulatory position.
  • Audit experience is essential.
  • Excellent verbal and written communication skills.
  • Excellent attention to detail.
  • Self-starter in terms of time and task management.
  • Strong technical writing ability.
  • Methodical review approach, capable of initiating and leading change.
  • Ability to work within a team environment to achieve agreed company goals.
  • Good understanding of ISO 27001, MDD v MDR & CE/UKCA.

Desired Skills & Experience:

  • Manage CE mark submissions, significant changes, and notified body interactions.
  • Manage the upcoming regulatory changes related to UKCA and MDR.
  • Manage regulatory assessment of any device/quality system changes.
  • Work with the commercial team to ensure country-specific registration activities are understood.
  • Lead management review process; report on the performance of the quality system.
  • Manage design control, change control, CAPA, risk management, product vigilance, and document control systems.
  • Lead strategic quality improvement projects and initiatives.
  • Lead product and facility inspections, preparation of procedures and instructions.
  • ISO 27001 management representative, manage all correspondence with notified body.
  • Previous experience in dealing with public tendering processes would be desirable.

What you will receive in return:

  • Competitive remuneration package.
  • Opportunity to work with a company that works with innovative products that impact millions of lives.
  • Healthy work-life balance, friendly work environment.
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