Regulatory Affairs Specialist
19 hours ago
Austin Vita is seeking a highly skilled Regulatory Affairs Specialist to join our team in a global medical device manufacturer based in the South East. This is a fantastic opportunity for a professional with a strong background in regulatory affairs to contribute to the success of our company.
Key Responsibilities- Support change management activities, collaborating with different departments across Quality, R&D, and Manufacturing to help manage sustaining changes across the medical device portfolio.
- Represent Regulatory Affairs in weekly change boards and ensure the appropriate regulatory action is taken during implementation of change.
- Work with counterparts globally, assessing potential impact of planned changes and communicating implemented changes.
- Generate and maintain technical documentation for compliance to applicable regulations.
- Support regulatory compliance projects, including EU MDR and NPD/sustaining projects.
- Drive process updates and contribute to process improvement.
- Medical Device Regulatory Affairs experience.
- University degree in a scientific subject.
- Excellent communication and organisational skills.
- Ability to work with cross-functional teams and diverse cultures.
Austin Vita 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.
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