Regulatory Affairs Executive

£30,000 - £39,999
08 Jan 2019
15 Jan 2019
Contract Type
Full Time
Regulatory Affairs Executive - International: An experienced Regulatory Affairs Executive - International is required for a growing RA & QA team for a leading healthcare company.

The Regulatory Affairs Executive - International 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.

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.

* 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

Skills & Experience:
* 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

* 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

This is a fantastic opportunity for an experienced Regulatory Affairs Executive - International, to join a global healthcare company at a time of sustained international growth. A competitive salary and benefits are on offer. Apply now!

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