Regulatory Affairs Expert

21 hours ago


Bristol, Bristol, United Kingdom Computerworld Personnel Ltd Full time

**About Us**

Computerworld Personnel Ltd is a rapidly growing organisation working with innovative products that have a genuine positive impact on the end user. Our business has exciting plans to significantly increase headcount on site due to increased market share and orders.

Job Overview

We are seeking an experienced Regulatory Affairs professional to join our team as a Senior Regulatory Specialist. This role will provide you with a generous benefits package including a matched 5% pension, alongside excellent soft benefits.

Key Responsibilities

  • Be part of NPD team and remediation activities to prepare and maintain technical files to ensure continuous compliance.
  • Preparation of submissions and communication with regulatory organisations.
  • Develop and implement regulatory strategy for NPD and existing products to maintain compliance.
  • Submission of regulatory applications and communications with international regulatory approvals.

Requirements

  • Able to lead RA activities and be the first point of contact for compliance enquiries.
  • Class 2A/B medical device experience.
  • Good regulatory application knowledge.

Salary and Benefits

The estimated salary for this role is £60,000 - £80,000 per annum, depending on experience. Additional benefits include free on-site parking, secure cycle shelter, discounts at local restaurant and gym, and an employee assistance programme.



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