This is a fantastic opportunity for a Regulatory 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 is able to offer relocation for the right candidate.
Benefits:
1. Annual leave that increases over your length of service
2. Flexible working hours
3. Hybrid working
4. Pension Scheme
5. 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 the implementation of change. The role will also work with counterparts globally, assessing the potential impact of planned changes and communicating implemented changes, so experience working in a global matrix environment would be ideal.
Other responsibilities include:
1. Generating/maintaining technical documentation for compliance with applicable regulations
2. Supporting regulatory compliance projects (EU MDR and NPD/sustaining projects for example)
3. Driving process updates and contributing to process improvement
Experience required:
1. Medical Device Regulatory Affairs
2. University degree in a scientific subject
3. Excellent communication and organizational skills
4. 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.
Check us out on our website 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.
Job Info:
Job Title: Regulatory Affairs Specialist
Company: CV-Library
Location: Competitive
Posted: Oct 11th 2024
Closes:
Sector: Medical, Pharmaceutical & Scientific
Contract: Permanent
Hours: Full Time
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