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.
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