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. Our reputation is based on a tradition of improvement, ethical leadership, and total commitment to quality and safety.

Welland Medical, established in 1988 is part of the CliniMed Group, and has over 240 colleagues committed to enhancing people’s lives.

Main Duties and Responsibilities

As a Regulatory Affairs Coordinator, your main responsibilities and duties will include:

• Support with regulatory strategies in New Product Development projects, from inception through to the Post-Market Surveillance phase, ensuring compliance to requirements throughout to support product launch
• Monitor and review regulatory and standard changes, highlighting any impact on the business
• Provide business-wide support, ensuring regulatory compliance with requirements applicable to Unique Device Identifiers, technical standards and design processes, including Design History Files
• Create and maintain Declaration of Conformity documents
• Prepare and maintain regulatory submissions
• Assist with maintaining and updating the technical files
• Create and maintain templates and other documentation to support compliance with global requirements
• Maintain device registration information in global systems
• Maintain and review risk management files and Post-Market Surveillance files
• Support Post-Market Surveillance & Vigilance tasks
• Support sales and commercial activities, particularly with enquiries from customers and market authorities, concerning regulatory issues
• Review and approve designs for packaging, labelling, instructions for use, marketing materials and technical documentation for compliance with relevant regulations and standards
• Create and maintain procedures to ensure regulatory compliance across the business
• Support the RA team in reviewing and maintaining clinical evaluation reports
• Support closure of general regulatory compliance issues as directed
• Support QARA during Notified Body audits, as directed by the Senior Regulatory Affairs Specialist and QARA Manager
• Lead assigned projects

Other Duties:

• A degree of flexibility is required, and you may be required to perform work not specifically referred to above and which will be appropriate to the level of the role. All duties must be carried out in compliance with processes defined as part of the company’s Quality Management System, Health and Safety Policies and the requirements of the applicable medical device legislation.

For more information please contact our recruitment team.