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Date Added: YESTERDAY

Regulatory Affairs Specialist

Nationwide, BB7, UK
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Company: CHR LIFE SCIENCES

Job Type: Permanent, Full Time

Salary: £40000 - £60000/annum

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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