Regulatory Affairs Specialist

3 weeks ago

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

This is a fantastic opportunity for a skilled 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).

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 (EU MDR and NPD/sustaining projects for example).
  • Drive process updates and contribute to process improvement.
Requirements:
  • 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 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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