Regulatory Affairs Specialist - 12 month FTC
Company
Austin Vita
Location
Essex
Employment Hours
Full Time
Employment Type
Permanent
Salary
Job Requirements/Description
This is a fantastic opportunity for a Regulatory Affairs Specialist to join a global medical device manufacturer based in the South East. The position is being offered on a 12 month Fixed Term Contract basis, and offers hybrid working (at least 2 days per week on site).
Benefits:
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:
Experience required:
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.
Check us out on our website and LinkedIn for more roles.
We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact (url removed) Austin Fraser International Ltd is registered in England: (phone number removed) Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU
Benefits:
- Flexible working hours
- Hybrid working
- Pension Scheme
- Private Medical Cover
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
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.
Check us out on our website and LinkedIn for more roles.
We respect your personal data and would never offer it to third parties! For more information on how we handle your data, feel free to check out the Austin Fraser Privacy Notice or contact (url removed) Austin Fraser International Ltd is registered in England: (phone number removed) Austin Fraser International Ltd, 33 Soho Square, London, W1D 3QU
Company
Austin Vita
Location
Essex
Employment Hours
Full Time
Employment Type
Permanent
Salary