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Regulatory Affairs Specialist

CHR Life Sciences
Posted 2 days ago, valid for 10 days
Location

Rotherham, South Yorkshire S65 1AJ, England

Salary

£40,000 - £60,000 per annum

Contract type

Full Time

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Sonic Summary

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  • CHR is seeking a Post-Market Surveillance Specialist with a strong background in data manipulation and clinical evaluations.
  • The ideal candidate should have a minimum of 4 years of specialized experience, particularly in PMCFP and clinical evaluations.
  • This project-based role will start on February 1st, 2025, and is expected to last approximately 3.5 months, with potential for extension.
  • Key responsibilities include conducting post-market surveillance, analyzing clinical data, and ensuring compliance with regulations.
  • The salary for this position is competitive, reflecting the expertise and experience required.

CHR is looking for a highly skilled Post-Market Surveillance Specialist with a strong background in data manipulation, statistics, and clinical evaluations. The ideal candidate will have approximately 4 years of specialised experience, preferably in PMCFP (Post-Market Clinical Follow-up) and clinical evaluations. The role involves managing a crucial project that will run for approximately 3.5 months with a view to extending, starting on February 1st, 2025, with a dedicated onboarding period.

Key Responsibilities

  • Conduct post-market surveillance activities related to their products (class 1 and 2 medical devices)
  • Analyse and manipulate data derived from clinical evaluations and PMS sources
  • Update and implement procedures and documentation for compliance with internal and external standards, including Health Canada regulations.
  • Manage deadlines and work autonomously while adhering to strict project timelines.
  • Prepare and present annual PMS data analysis, including both positive and negative findings
  • Collaborate with cross-functional teams to ensure timely updates to quality management systems and documentation
  • Facilitate training for new staff and assist in their transition into the team

Qualification Requirements

  • Minimum of 4 years experience in post-market surveillance, clinical evaluations, or a related field
  • Strong skill set in data manipulation and statistics
  • Proven experience in managing multiple priorities and maintaining adherence to deadlines
  • Detail-oriented with excellent problem-solving skills
  • Proficient in using relevant software tools for data analysis and documentation management

Why Join?

Be part of a dynamic team that plays a critical role in ensuring the safety and efficacy of medical devices through robust post-market surveillance practices. Your expertise will directly contribute to upholding the standards of quality and regulatory compliance within innovative healthcare solutions.

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