Regulatory Affairs Specialist

Overview

Our Client, a well established and successful Global Medical Device business, have an exciting opportunity for a Regulatory Affairs Specilaist to join the Team.

Your duties will include the development and review of product technical documentation such as medical device files and all related documents to demonstrate regulatory compliance to the Notified Body as well as regulatory dossiers required for submissions of registrations to the competent authorities where the company intends to market their products.

Benefits

• Annual leave entitlement of 26 days + bank holidays
• Defined contribution pension scheme - (6% employee + 12% employer = 18%)
• Hybrid working
• Life assurance (all employees receive a minimum of 3 x salary, if enrolled into the company pension scheme, this goes up to 6 x salary)
• Private medical cover

Responsibilities

• Maintain technical information related to the summary of technical documentation (STED), such as Declarations of Conformity (DofC), Device Master Records (DMRs) and any other which may be required as part of CE certification, UKCA and registration activities
• Manage Engineering Change Request/ Engineering Change Order (ECR/ECO) process including notifications of changes which are notifiable under local regulations
• Drive Regulatory Affairs procedural updates, as needed, in collaboration with cross functional inputs
• Support new product development
• Execute international product registrations according to individual country specific requirements
• Registration of product portfolio with MHRA and support activities for compliance to UK regulations
• Review of promotional materials
• Support Commercial teams with tender/bid applications

Skills and experience

• University degree in a scientific subject, such as Biomedical Science, Pharmacy, Engineering or similar discipline
• Experience in regulatory affairs, quality or R&D in the medical device industry
• Good understanding of the regulatory framework applicable to medical devices
• Ability to interpret legislative text
• Excellent communication and negotiation skills
• Good organisational skills
• Ability to work in a team

For immediate consideration please forward your most up to date CV

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.