RA Specialist

Cambridge
2 weeks ago
Applications closed

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Senior Regulatory Affairs Manager - Global Clinical Services

Selexa Life Sciences are partnered with a leading IVD client in Cambridge as they continue to grow and expand their Regulatory function. As an RA Specialist, you will be responsible for ensuring products are safe, effective, and fit-for-purpose.

The role is a pivotal part of the Regs team, enabling regulatory compliance of our clients products and ensuring effective performance, clinical validation and manufacturing compliance.

The Role:

  • Possess and maintain a good working knowledge of regulatory frameworks across the UK, EU and US

  • Maintain a good knowledge of our clients product portfolio in terms of technical understanding, clinical purpose and regulatory frameworks

  • Provide input into regulatory strategy, submission & approvals for new product developments and manufacturing changes

  • Work cross-functionally to support tasks relation to regulatory submissions

  • Provide technical guidance on Regs requirements

  • Update on progress of product registration processes and other RA activities in line with business requirements

  • Liaise with product managers and other key stakeholders to maintain product technical documentation and records supporting the Quality Management System.

    Qualifications & Experience:

  • Degree level education in relevant Life Sciences/Biomedical Eng discipline

  • 1-3 Years IVD/medical device experience

  • Working knowledge of ISO13485 as well as 21 CFR 820

  • Pre/Post Market knowledge, surveillance and vigilance

    This is an excllent opportunity for RA Specialists or Associates to join a leading IVD client, with a strong product range under the leadership of Senior RA professionals, gaining exposure and fantastic Regs and NB experience

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