- Job Title: Senior Regulatory Affairs Executive – Medical Devices
- Location: Kingston
- Generous Benefits Package Including Pension, Healthcare, Life Assurance, Bonus and Others
- Excellent Opportunity to Take Ownership of an Influential and Strategic Role
Summary
James Hume is recruiting for a Senior Regulatory Affairs Executive to take ownership of an influential position with the responsibility for all regulatory matters linked to Medical Devices. They are well-established leading eye care organisation who have been at the forefront of visionary innovations since their conception with a market leading presence in the UK. Reporting directly to the Head of Regulatory Affairs you will have responsibility for all matters relating to Medical Devices covering post and pre-market activities
Company Description
The company are a leading and rapidly evolving eye care organisation with the mission to enhance the quality of life of their patients by improving their vision. As part of a wider global organisation they are well placed to achieve their aim and they are still developing new technologies to improve patient’s quality of life. They have a broad range of products that covers surgical medical devices, contact lenses and associated consumables, OTC products, pharmaceuticals and others. They have a unique culture based on working collaboratively to achieve the company’s goals taking a professional and committed approach. In the UK they have c150 employees which means they take a small company approach to their work, further enhancing the collaborative and dynamic nature of their culture.
The Opportunity:
This is a broad and influential role where you will be working with the Head of Regulatory affairs by taking control of all matters relating to pre-and post marketing activities at a both a strategic and hands on level covering the UK and Ireland. For example, you will ensure that all post marketing quality and regulatory affairs requirements are met. Regarding the pre-marketing activities you will be working collaboratively to support the design assurance team to ensure all compliance requirements are met. Other examples of areas you will be involved in are the review of all promotional material, artwork, resolve issues and ensure company compliance to ISO 13485 regulations.
There is a strong strategic element with the need to work closely with the Head of Regulatory Affairs to define the strategy for the company, provide direction, act as the technical expert for global queries from the wider group and to ensure that they keep up to date with developments in the market. Using your knowledge and experience to develop this and ensure the changing business and regulatory needs of the company are met.
Desirable Skills and Experience:
You will need to have relevant experience of witching medical device regulatory affairs with in – depth knowledge of applicable regulations to the UK and Ireland. With demonstrable experience of post and pre-marketing activities relating to medical devices including IVD. You will need to have experience at working in a senior capacity with influence across the company and the ability to work in a dynamic environment.
Key words:
Regulatory Affairs, Associate, Officer, Executive, Specialist, OTC, Over The Counter, Pharmaceuticals, Pharma, Medical Devices, UK, Europe, England, London, Berkshire, Buckinghamshire, Greater London, ISO 13485, marketing authorisation, variations, line extensions, renewals, IVD, invitro diagnostic, med dev, artwork, advertising, post market, pre market, promotional, MHRA, UK, Ireland, 93/42/EEC.