BASED LIVINGSTON EXCELLENT BASE SALARY PLUS EXTENSIVE BENEFITS
Based in Livingston, our client is a well-known and highly successful medical device business. From their manufacturing facility in Livingston, the company supply medical device products across a range of markets. The business is going through a period of growth as they move into new geographical regions, therefore, require a talented Regulatory Affairs Specialist with a background in FDA submissions.
Reporting into the Head of Regulatory Affairs, the Regulatory Affairs Specialist will prepare and maintain regulatory submissions in the USA in accordance with the business strategy and objectives. You will proactively keep abreast of new regulatory requirements and standards and develop regulatory strategies for new products to ensure seamless development and launch to the market. You will support planning and roll out of changes to registered products and ensure that all regulatory requirements are met. Other key responsibilities will include:
- Responsible for the preparation and submission of Regulatory filings including PMA applications and supplements. Ensures that all regulatory requirements are met for the US market.
- Liaises with regulatory authorities as necessary during regulatory submission process to ensure approvals are obtained in line with launch plan.
- Proactively keeps abreast of new regulatory requirements and standards and provides expert advice and guidance to other RA team members and project stakeholders.
The candidate will ideally be educated to degree level in a Scientific or other closely relevant discipline. The relevant candidate will have an understanding of USA and other international regulatory requirements, including experience of filing PMA or 510(k)s. Ideally you will have proven experience in medical device Regulatory Affairs, preferably with Class III devices, in the USA.
This business is going through massive growth and positive change at this time. Enhanced job security can be taken as a given. You will also be at the forefront of their regional growth strategy. In return for your hard work and effort, you can expect an excellent basics salary, training and development, flexible working solutions and a comprehensive benefits package that includes health care, pension and a performance related bonus.
To apply to this role please send your CV to our recruitment partner Katie Hydes at ESS Recruit in Edinburgh.