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  • Regulatory Affairs Consultant - Bristol - Computerworld Personnel Ltd

    Computerworld Personnel Ltd
    Computerworld Personnel Ltd Bristol

    4 weeks ago

    Default job background
    Description

    Senior Regulatory Specialist

    • Generous Salary Package: Highly competitive salary, bonus opportunity, and a range of benefits.
    • Benefits: 25 days + bank holidays, employee assistance programme, matched 5% pension, funded company social events, free on-site parking, and secure cycle shelter.
    • Discounts: Exclusive discounts at local restaurants and gyms.
    • You are an experienced Regulatory Affairs professional looking for a challenging opportunity. This role is ideal for someone who wants to join a rapidly growing organisation with a product that has a genuine positive impact on the end user. The business has exciting plans to expand its operations due to increased market share and orders.

      Key Responsibilities

      • Be part of the NPD team and remediation activities to prepare and maintain technical files ensuring continuous compliance.
      • Prepare submissions and communicate with regulatory organisations.
      • Develop and implement regulatory strategy for NPD and existing products to maintain compliance.
      • Submit regulatory applications and communicate 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 knowledge of regulatory applications.

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