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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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