Regulatory Affairs Executive - International
Regulatory Affairs Executive – International: Due to impressive, sustained growth a customer-focussed Regulatory Affairs Executive with knowledge of cross border regulations is required to handle all aspects of international regulatory compliance for one of the UK’s fastest growing healthcare companies. The successful candidate will join GAMA Healthcare working under the Regulatory Affairs Manager working to achieve regulatory compliance across a variety of product types and areas 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. The ideal candidate will have previous project coordination experience, preferably in a medical devices, cosmetics, biocides or pharma industry. They’ll be a natural communicator with the ability to build a rapport with customers and suppliers that may not speak English as a first language. GAMA Healthcare is a dynamic and successful international healthcare company specialising in the design, commercialisation, manufacture and distribution of innovative, high quality infection control products. In less than 14 years revenues now account for a turnover in excess of £33million and double-digit growth is forecasted over the next 5 years, by expanding infection control sales and introducing innovative products into the wound care market. 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 was also recognised by The Sunday Times for the HSBC International Track 200 Award. Responsibilities: Ensure that GAMA achieves registrations and licences in line with relevant regulatory frameworks to enable product sales; including 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 Skills & Experience: Previous experience within a relevant Regulatory Affairs role Previous working experience in an international environment, ideally in Health or Medical Device areas Experience in interacting with regulatory agencies Good organisation, planning and collaborative skills Ability to communicate clearly and concisely internally 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) Project management awareness Works well under pressure but with attention to detail Comfortable working across different countries and time zones Excellent English-language written and verbal skills Microbiology / awareness of infection control (Desirable) This is a fantastic opportunity for an experienced Regulatory Affairs Executive to join a global healthcare company at a time of sustained international growth. A competitive salary and benefits package are on offer. Apply now!