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    Aylesbury, Buckinghamshire, United Kingdom Austin Vita Full time

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Regulatory Affairs Specialist

2 months ago

Aylesbury, Buckinghamshire, United Kingdom Austin Vita Full time
Job Description

Austin Vita is seeking a skilled Regulatory Affairs Engineer to join our client, a leading medical device manufacturer based in the UK. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and industry standards.

This is a site-based role that requires a hands-on approach, working closely with cross-functional teams to develop and implement regulatory strategies. If you are a detail-oriented professional with a passion for quality and compliance, we encourage you to apply.

Key Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with industry standards and regulations.
  • Collaborate with cross-functional teams to design and develop medical devices that meet regulatory requirements.
  • Conduct risk assessments and implement mitigation strategies to ensure product safety and efficacy.
  • Prepare and submit regulatory documents, including technical files and clinical trial reports.
  • Stay up-to-date with changing regulatory requirements and industry standards.

Requirements:

  • Proven experience in regulatory affairs, quality assurance, or a related field.
  • Strong knowledge of medical device regulations, including ISO 13485 and FDA regulations.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.