Regulatory Affairs Assistant

Regulatory Affairs Assistant - International Registrations

Industry: Medical Devices

Location: Plympton, Plymouth

Contract Type: Permanent

About The Company

The company is a leading independent developer and manufacturer of innovative products for the global advanced wound care, wound closure, and surgical markets. With a workforce of over 700 employees worldwide, it fosters a collaborative and dynamic work environment focused on innovation, personal development, and growth.

Focus of the role

Submit and maintain global regulatory approvals to meet the requirements of the business plan.

Support regulatory submissions for entry into new markets and maintain registrations and licenses in existing markets.

Assist with customer audit requests, tender requests, and other general inquiries related to international registrations.

Role Responsibilities

• Compile and submit regulatory submissions for approval in applicable markets.
• Maintain current registrations, licenses, regulatory certifications, and submissions to ensure compliance with the latest medical device frameworks in the registered countries.
• Support and advise various business functions on information and registration requests.
• Coordinate the preparation, review, and timely submission of responses to requests for additional information from regulatory authorities regarding product registrations.
• Assist with customer market registration activities in accordance with existing contractual obligations.
• Participate in and support audits and reviews by regulatory authorities and customers related to the international registration system, including preparation, facilitation, and response.
• Monitor relevant industry-wide international registration activities.
• Contribute to the continuous improvement and development of the international registrations process.
• Promote and demonstrate the core values of Care, Fair, and Dare in the workplace.
• Ensure adherence to health and safety policies in the workplace.
• The role involves frequent interaction with customers, in-country agents, regulatory authorities, Quality, Marketing, R&D, and Clinical teams.
• Implement and manage the international registration system for the organization.
• Due to the nature of the role, the individual must effectively manage critical deadlines, workloads, and time to meet regulatory timelines.

Role Requirements

• Science based degree (or equivalent), or relevant experience of working in the medical device field, preferably in a regulatory role.
• Ideally has experience in key market approval requirements within APAC, EMEA and LATAM Regions
• Excellent communication skills both written and verbally with employees, customers, in country agents and Regulatory Authorities.
• Competent IT skills
• The ability to influence and challenge others in a constructive way to deliver improvements.

Salary & Benefits

£25,000 - £30,000 (depending on experience)

• Pension Scheme
• Life Assurance
• Medical & Healthcare
• Cycle to Work Scheme

…and much more, please ask to see full benefits package.

If you are interested in this position and would like your application to be considered, please send over your CV to me on .