Regulatory Affairs Specialist

6 days ago

Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time
Job Description

Oxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. As a Post Market Surveillance Manager, you will play a critical role in ensuring the quality and safety of our products.

Key Responsibilities
  • Coordinate post-market surveillance activities in accordance with the company's Quality Management System (QMS) policies and procedures.
  • Ensure that post-market surveillance plans for individual products are implemented and met.
  • Work closely with technical services and external partners to gather, triage, escalate, and complete post-market surveillance information.
  • Coordinate cross-functional teams to conduct investigations, gather information, analyze data, and report findings.
  • Establish and maintain post-market surveillance information sources to gather customer feedback, monitor product field performance, and report findings.
  • Provide timely information to the Regulatory Affairs Manager for vigilance reporting.
  • Educate staff on post-market surveillance requirements and procedures.
  • Work with the Regulatory Affairs Manager and Quality Assurance team to maintain and improve post-market surveillance procedures and processes.
  • Prepare and present post-market surveillance reports and updates.
Requirements
  • Good grounding in IVD device regulations, specifically post-market surveillance requirements.
  • 3 or more years of experience working in a regulatory affairs team within the diagnostics industry.
  • Strong working knowledge of 21CFR, IVDR, and ISO 13485.
  • Strong communication, writing, analytical, and problem-solving skills.
  • Ability to work effectively in a team environment and make decisions.
What We Offer

Oxford Nanopore Technologies offers a competitive salary, attractive bonus, generous pension contributions, private healthcare, and a wonderful working environment. If you are looking to utilize your skills to make a difference in the biotechnology industry, consider joining our team.

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