Senior Regulatory Specialist

Cardiff CF14

Commutable from Cardiff, Newport, Bridgend, Caerphilly, Barry, Llantrisant, Pontypridd

Benefits:-

• Highly competitive salary
• Bonus Opportunity
• 25 Days + Bank Holidays
• Employee assistance programme
• Matched 5% pension
• Funded company social events
• Free on-site parking and secure cycle shelter
• Discounts at local restaurant and local gym

Are you an experienced Regulatory Affairs professional? This could be the perfect opportunity for you to join a rapidly growing organisation working with a product has a genuine positive impact on the end user. The business has exciting plans to significantly increase the headcount on site due to increased market share and orders. This role will provide you with a generous benefits package including a matched 5% pension, alongside excellent soft benefits.

Responsibilities

• Design and implement QMS for design control
• Be part of NPD team and remediation activities to prepare and maintain technical files to ensure continuous compliance.
• Preparation of submissions and communication with regulatory organisations.
• Develop and implement regulatory strategy for NPD and existing products to maintain compliance.
• Submission of regulatory applications and communications with international regulatory approvals.
• Surveillance of new standards and ensuring NPD meets recognise consensus standards.

Requirements

• Medical Device experience is an essential for this role.
• Able to lead RA activities and be the first point of contact for compliance enquiries.
• Able to manage day-to-day activities and tasks, and work independently in RA matters.
• Class 2A/B medical device experience.
• Good regulatory application knowledge.

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If you are interested in this role or looking for something similar please contact Jack Lavis directly at jackl@hunterselection.co.uk or call for a confidential discussion on 02920 894900.