ABOUT WELLAND MEDICAL LTD:

Welland Medical brings to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Investing in the most talented people, collaborating to create world-class, ground-breaking products and services devoted to improving peoples’ lives. We are passionate about making a difference in the world.
Welland Medical is a part of Clinimed Holdings Limited, a prominent figure in the Healthcare and Medical Equipment sector. Clinimed Holdings Limited comprises a group of companies established in 1982 through the acquisition and formation of various entities within the group.

JOB SUMMARY:

The Regulatory Affairs Coordinator plays a vital role in the success of the Quality Assurance and Regulatory Affairs (QARA) department by ensuring compliance with all relevant regulations, standards, and guidelines. This role involves maintaining regulatory documentation, overseeing assigned processes, and representing Regulatory Affairs in key business projects.
Additionally, the Coordinator will provide regulatory guidance to internal stakeholders, ensuring records, documents, and products consistently meet compliance requirements.

• Assist in developing regulatory strategies for New Product Development projects, ensuring compliance from inception through Post-Market Surveillance to support successful product launches.
• Monitor and assess regulatory and standard changes, identifying potential business impacts.
• Provide company-wide support to ensure compliance with Unique Device Identifier requirements, technical standards, and design processes, including Design History Files.
• Prepare, maintain, and update regulatory submissions, technical files, and Declaration of Conformity documents.
• Develop and manage templates and documentation to support global regulatory compliance.
• Maintain device registration records in global systems.
• Review and update risk management and Post-Market Surveillance files.
• Support Post-Market Surveillance and Vigilance activities.
• Assist sales and commercial teams with regulatory inquiries from customers and market authorities.
• Review and approve packaging, labeling, instructions for use, marketing materials, and technical documentation to ensure regulatory compliance.
• Develop and maintain procedures to ensure ongoing regulatory compliance across the business.
• Assist the Regulatory Affairs team in reviewing and maintaining clinical evaluation reports.
• Support resolution of regulatory compliance issues as directed.
• Assist QARA during Notified Body audits under the guidance of the Senior Regulatory Affairs Specialist and QARA Manager.
• Take ownership of assigned regulatory projects.