Quality Assurance Specialist – Due to impressive and sustained growth an experienced Quality Assurance Specialist with a highly organised approach and knowledge of the medical devises regulations is required for a growing RA & QA team for a leading healthcare company.
The Quality Assurance Specialist 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.
• Proactively build / strengthen external stakeholder contacts (e.g. certification bodies, industry organisations and business partners)
• Interact with consultants as required
• Interact with and advise project teams as assigned
• Respond to enquiries from internal and external stakeholders
• Maintenance of the Quality Management System
• Deputise for QA Manager
• Management of controlled documents
• Contribute towards the development and management of supplier quality agreements (QTAs)
• Collation / analysis of post market surveillance (PMS) data for medical devices
• Management of the supplier qualification process
• Handling customer complaints (investigation; documentation; communication)
• Handling the Corrective and Preventative Action Process
• Preparing, submitting and following up on medical device vigilance reports
• Creation and control of product specifications
• Liaison with equipment manufacturers regarding product compatibility
• Maintain an awareness and ensure compliance with relevant regulations and laws in all markets. Monitor and communicate changes to applicable regulatory requirements
• Provide advice on quality assurance requirements to key stakeholders as appropriate
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
• Good organisation / planning skills
• Strong Technical writing skills
• Ability to conduct investigations
• Strong Data Analysis skills
• Ability to work as part of a team
• 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
• Relevant industry experience, ideally in Health or Medical Device areas
• Works well under pressure but have attention to detail
• Excellent English-language written and verbal skill
• Microbiology / awareness of infection control (Desirable)
• Excellent interpersonal skills
This is a fantastic opportunity for an experienced Quality Assurance Specialist – Regulatory, to join a global healthcare company at a time of sustained international growth. A competitive salary and benefits are on offer. Apply now!