Regulatory Affairs Specialist

1 week ago


Southampton, Southampton, United Kingdom Austin Vita Full time
Regulatory Affairs Specialist Opportunity

This is a fantastic opportunity for a skilled Regulatory Affairs Specialist to join Austin Vita, 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.

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 the implementation of change.
  • Work with counterparts globally, assessing the potential impact of planned changes and communicating implemented changes.
Additional Responsibilities:
  • Generate and maintain technical documentation for compliance with applicable regulations.
  • Support regulatory compliance projects, including EU MDR and NPD/sustaining projects.
  • Drive process updates and contribute to process improvement.
Requirements:
  • Experience in 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.


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