Job Title: Regulatory Affairs Specialist
Description:
The Regulatory Affairs Specialist will play a critical role in ensuring the company's products meet and exceed regulatory standards, driving long-term success.
About Us:
Our client is a leading player in the Healthcare Distribution Industry, expanding and experiencing significant growth and innovation. They are seeking an experienced professional to join their team.
Key Responsibilities:
* Ensure all products comply with regulatory requirements, managing non-compliant suppliers and implementing corrective actions.
* Monitor and manage changes to UKCA, MDR, and global regulations, maintaining audit-readiness for customers and authorities.
* Lead strategic quality improvement projects to strengthen the company's position in the market.
* Oversee Design Control, Change Control, Risk Management, Product Vigilance, and Document Control Systems.
* Manage assessments of device/quality system changes, collaborating with stakeholders as needed.
* As ISO Quality Management representative, handle correspondence with Notified Bodies for certification purposes.
Requirements:
* A minimum of 3 years' experience in a regulatory position within the medical device/healthcare industry.
* Qualification in Regulatory Affairs or a related field is essential.
* The ideal candidate will be a self-starter, able to operate with minimal supervision.
* Strong knowledge of ISO, MDD, MDR & CE/UKCA regulations.
* Excellent time management, attention to detail, and analytical skills.
* Proven ability to lead change and continuous improvement initiatives.
Company Overview:
Our client values innovation, growth, and excellence in the healthcare distribution industry. This role offers an exciting opportunity to contribute to their success and advance your career.