This is a fantastic opportunity for a Regualtory Affairs Specialist to join a global medical device manufacturer based in the South East. The position offers hybrid working (at least 2 days per week on site) and are able to offer relocation for the right candidate.

Benefits:

Annual leave that increases over your length of service
Flexible working hours
Hybrid working
Pension Scheme
Private Medical Cover

The Role
You will be involved in supporting change management activities, collaborating with different departments across Quality, R&D, and Manufacturing to help manage sustaining changes across the medical device portfolio, incorporating the review/approval of change requests.

You will represent Regulatory Affairs in weekly change boards and ensure the appropriate regulatory action is taken during implementation of change. The role will also work with counterparts globally, assessing potential impact of planned changes and communicating implemented changes so experience working in a global matrix environment would be ideal.

Other responsibilities include:

Generating/maintaining technical documentation for compliance to applicable regulations
Supporting regulatory compliance projects (EU MDR and NPD/sustaining projects for example)
Driving process updates and contributing to process improvement

Experience required:

Medical Device Regulatory Affairs
University degree in a scientific subject
Excellent communication and organisational skills
Ability to work with cross-functional teams and diverse cultures

For immediate consideration please forward your most up to date CV

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.

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Regulatory Affairs Specialist