Regulatory Compliance Specialist

2 weeks ago

Worcester, United Kingdom Redwood Search Full time
About the Role

Redwood Search is seeking a highly skilled Post-Market Surveillance Associate to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring the company's medical devices meet regulatory requirements and drive continued product improvements.

Key Responsibilities:
  • Establish Post-Market Surveillance Plans: Develop and implement post-market surveillance plans to gather and analyze clinical data from various sources, including direct feedback from user surgeons, customer complaints, patient-reported outcome measures, and published clinical literature.
  • Complete Regulatory Reports: Prepare and submit Periodic Safety Update Reports (PSURs) and Summaries of Safety and Clinical Performance (SSCPs) to regulatory authorities.
  • Manage Clinical Data: Proactively gather post-market data from healthcare professionals and manage clinical data collection from various sources, including direct feedback from user surgeons, customer complaints, patient-reported outcome measures, and published clinical literature.
  • Collaborate with Clinical Research Organizations: Assist in activities of Clinical Research Organizations (CROs) during clinical investigations as required.
  • Contribute to Regulatory Documentation: Input into Clinical Evaluation Reports (CERs), internal product reviews, vigilance reporting to regulatory authorities, customer complaint investigations, and technical file documentation relating to clinical performance and associated risks.
Requirements:
  • Attention to Detail: Essential for ensuring accuracy and completeness of regulatory reports and documentation.
  • Report Writing Ability: Strong writing skills to prepare clear and concise reports and documentation.
  • Data Analysis: Ability to analyze and interpret clinical data to inform regulatory decisions.
  • Problem-Solving Skills: Strong problem-solving skills to identify and address regulatory issues.
  • Communication Skills: Excellent communication skills to develop relationships with external partners, including orthopaedic surgeons, and work with staff at differing levels of the organization.
  • Team Player: Ability to work collaboratively as part of a team to achieve regulatory compliance and product improvements.

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