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Collingwood
,
Clitheroe, Lancashire
Quality Assurance Director
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Job Type: Full-time |
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Salary: £60,000 per annum |
Overview
We are looking for a people and customer orientated leader to ensure the global regulatory affairs and quality assurance process and platform enables the company to facilitate exponential growth. The role is based in Northern England and will involve international travel. The Person - Experience we are looking for A four-year degree (an emphasis on health science would be a plus) Minimum of 10 years of Quality Management, Quality Assurance and, ideally but not essentially, Regulatory Affairs leadership experience in the medical device industry, with responsibilities for managing others Ability to read, understand and interpret medical device, FDA and EU regulations and requirements and understand and interpret contractual agreements, patents, legal documents, advance technical articles and professional scientific journals Position presents training to all employees on U.S. FDA Quality System regulations, ISO 13485, and updates management on new regulatory issues The Opportunity Reporting to a Group Board Director Overseeing the development of the group’s quality assurance and regulatory affairs strategy and ensuring it will be fit for purpose while the company achieves significant growth Working closely with all key stakeholders to ensure compliance at all times through proactive monitoring, education and action Developing regulatory strategies for U.S. and other regulated markets Serving as Official FDA Correspondent (OC): is responsible for the annual registration of the establishment and the device listing. The OC also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments. The Official Correspondent is responsible for: Our Client A well established UK business, our client is part of a very successful global group involved in the design, development and manufacture of medical devices. They have a fantastic, people oriented culture, are well respected as an industry leader and in recent years, have been investing significantly across their many manufacturing sites around the world. The company has embarked on an exciting growth plan in which it aims to almost double its revenue in the next 5 years. This will be achieved by realigning the organisation to focus on market opportunities and its investment in product innovation.