Regulatory Affairs Executive

Company Overview

GAMA Healthcare is a global company with over 150 staff with offices based in the United Kingdom, Australia and China. We are market leaders in various infection prevention and control solutions, our range of Clinell products combine innovative technology with ease of use, providing the professional healthcare industry with the most effective options available. Our mission is to reduce worldwide infections by offering the best innovative solutions together with market leading after sales support.

Founded in 2004 by two medical doctors, GAMA Healthcare has become a world leading developer and manufacturer of infection prevention technology. The Clinell brand is well known to the NHS, providing a range of product lines for surface care, hygiene monitoring, and patient skincare.

In April 2018 GAMA Healthcare received the Queens Award for Enterprise in International Trade and were also recognised by The Sunday Times for the HSBC International Track 200 Award. In less than 10 years, revenues now account for a turnover in excess of GBP30 million and double-digit growth is forecasted over the next 5 years.

Role overview

GAMA Healthcare seeks an experienced, Regulatory Affairs Executive for our growing RA & QA team. The successful candidate will handle all aspects of regulatory compliance across many areas of product type or area of legislation.

This role primarily involves obtaining and managing registrations, clearances and licences in GAMA's international markets, as well as maintaining an awareness of regulatory requirements, advising the business on regulatory topics and supporting projects teams.

Key requirements

• Previous experience within a relevant Regulatory Affairs role.
• Previous working experience in an international environment.
• Experience in Interacting with regulatory agencies.
• Good organisation & planning skills.
• Strong collaborative skills.

Who we are looking for

• Ability to communicate clearly and concisely internally and with all stakeholders.
• Knowledge of relevant Regulations, Standards and Compliance requirements with respect to the company products whether directly or through associates and contacts. (Desirable)
• Ability to influence effectively internally while maintaining good working relationships.
• Microsoft Office Proficient
• Project management awareness.
• Relevant industry experience, ideally in Health or Medical Device areas.
• Works well under pressure but have attention to detail
• Comfortable to work across different countries and time zones.
• Excellent English-language written and verbal skill.
• Microbiology / awareness of infection control (Desirable).
• Excellent interpersonal skills.

Duties and Responsibilities

• Ensure that GAMA achieves registrations and licences in line with relevant regulatory frameworks to enable product sales. This includes interpretation of requirements; compilation and submission of dossiers and ensuring suitability of product labelling.
• Maintain an awareness and ensure compliance with relevant regulations and laws in all markets. Monitor and communicate changes to applicable regulatory requirements
• Track / report on assigned projects (timelines/costs)
• Ensure regulatory compliance of product labelling and advertising
• Manage relevant technical documentation and files
• Interact with consultants as required
• Ensure technical documentation meets international regulatory requirements.
• Prepare and submission of registration dossiers (using third parties as necessary).
• Respond to enquiries from internal and external stakeholders
• Provide advice on quality and regulatory requirements to key stakeholders as appropriate.
• Confirm export registration schedule. Prioritisation / validation of requests with Export group
• Compile dossiers for all products types in international markets
• Liaison with relevant country contacts