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Regulatory Affairs Manager - Healthcare
 
Title: Regulatory Affairs Manager - Healthcare
Category: Security / Protective Services
Job type: Permanent
Job status: Full Time
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Description:
Regulatory Affairs Manager - Healthcare: An experienced, solution-focussed Regulatory Affairs Manager is required to manage and develop a team of Regulatory Specialists and all aspects of pre and post-market regulatory compliance matters across a broad range of product categories for a leading healthcare company.

The Regulatory Affairs Manager will lead in maintaining an awareness of regulatory requirements whilst also advising the business on regulatory topics, supporting the NPD pipeline by ensuring market access and handling post-market regulatory issues in line with relevant requirements.

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:

*Maintain awareness/ensure compliance with relevant regulations and laws

*Clarify regulatory roles within projects and manage registration requests/priorities

*Follow up, escalate and resolve regulatory issues

*Respond to enquiries from all stakeholders (regulators; trade bodies; government bodies)

*Oversee NPD projects and progress of product registrations

*Identify and scope out new regulatory projects (timelines/costs)

*Provide advice on quality and regulatory requirements to key stakeholders as appropriate

*Select, monitor and manage external regulatory consultants

*Manage and support Regulatory Specialists to achieve their responsibilities and objectives

*Overall responsibility for project progress and compliance of product areas within scope of role

*Deputise for RA/QA Director on regulatory topics

Skills & Experience:

*Bachelor's Degree in Science or Equivalent

*Seasoned Regulatory Affairs professional with broad knowledge of regulatory requirements for medical devices including registration, manufacturing and post market controls

*Demonstrable experience of managing regulatory professionals

*Demonstrable experience of product registration processes

*Extensive experience of working with ISO 13485 & ISO 14971

*Previous exposure to regulatory project budgets

*Microbiology / awareness of infection control

*Previous staff management experience

*Extensive knowledge of Regulations, Standards and Compliance requirements for medical devices (essential)

*Knowledge of Biocides; Cosmetics; Pharmaceutical regulations (desirable)

*Strong negotiation and influencing skills

*Ability to communicate clearly and concisely internally and with all stakeholders

*Strong collaborative skills

*Ability to influence effectively internally while maintaining good working relationships

*Advise internally/externally on all matters relating to the scope of the role

*Handling compliance issues with serious potential impact

*Representation for GAMA with Government Authorities, Registrars, Trade associations, customers and working groups

*Excellent English-language written and verbal skills

This is a fantastic opportunity for an experienced Regulatory Affairs Manager 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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