Regulatory Affairs Executive

Circa £32,000 p.a. plus performance bonus and benefits

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.
Bachelor Degree in Science or equivalent
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

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