Job Description
Regulatory Affairs Specialist sought for a leading Healthcare Distribution company in County Offaly, Ireland. The ideal candidate will ensure compliance with regulatory standards and drive quality improvement projects.
Our client is a dynamic company in the healthcare industry, currently experiencing growth and innovation. They are seeking a Regulatory Affairs Specialist to join their team and contribute to their long-term success.
The successful candidate will report directly to the Managing Director and enjoy autonomy in ensuring all products meet and exceed internal and external regulatory standards. Key responsibilities include:
- Identifying compliant and non-compliant products with regulatory requirements
- Managing regulatory changes related to UKCA and MDR
- Ensuring products and paperwork are audit-ready for customers and regulatory bodies
- Leading quality improvement projects to strengthen the company's success
- Overseeing Design Control, Change Control, Risk Management, and Document Control Systems
- Managing assessments of device/quality systems changes
- Representing the company in correspondence with Notified Bodies for certification
The ideal candidate will possess:
- A minimum of 3 years' experience in a regulatory position within the medical device/healthcare industry
- Qualification in Regulatory Affairs or a related field
- Strong knowledge of ISO, MDD, MDR, and CE/UKCA
- Excellent time and task management skills, with attention to detail
- A systematic approach to reviewing processes and leading change
The company values a self-starter who can operate with minimal supervision and is committed to continuous improvement. If you are a motivated and organized individual with a passion for regulatory affairs, please submit your CV for consideration.