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Medical Device Surveillance Specialist

2 months ago


Worcester, Worcestershire, United Kingdom Redwood Search Full time
{"Job Title": "Post Market Surveillance Associate", "Job Description": "Job Summary

Redwood Search is seeking a highly skilled Post Market Surveillance Associate to join our client's team in the medical device sector. As a key member of the quality assurance team, you will be responsible for gathering and analyzing clinical data to ensure compliance with regulatory requirements.

Key Responsibilities
  • Develop and implement post-market surveillance plans to monitor the safety and performance of medical devices.
  • Collaborate with cross-functional teams to gather and analyze clinical data from various sources, including direct feedback from user surgeons, customer complaints, and published clinical literature.
  • Produce high-quality reports, including Periodic Safety Update Reports (PSURs) and Summaries of Safety and Clinical Performance (SSCPs), to support regulatory submissions.
  • Work closely with Clinical Research Organisations (CROs) during clinical investigations and provide input into Clinical Evaluation Reports (CERs) and internal product reviews.
  • Contribute to vigilance reporting to regulatory authorities and customer complaint investigations.
Requirements
  • Strong understanding of medical device regulations, including ISO 13485 and 21 CFR Part 820.
  • Excellent analytical and problem-solving skills, with attention to detail and ability to work independently.
  • Effective communication and interpersonal skills, with ability to collaborate with staff at all levels of the organization.
  • Ability to work in a fast-paced environment and prioritize multiple tasks and deadlines.
What We Offer

Our client offers a competitive salary and benefits package, as well as opportunities for professional growth and development in a dynamic and innovative company.

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