Regulatory Affairs Manager

Regulatory Affairs Manager

Smith & Nephew

Hull, United Kingdom

Summary

This role will be responsible for line management of 2-3 individuals as well as focusing on products that have already gone through a first launch and require additional support elsewhere in the world. Including line management responsibility, this role offers diversity from the typical RA Specialist position and a challenge that combines for a unique opportunity for an experienced Regulatory Affairs professional.

Essential Job Functions

  • To provide on-going regulatory advice to project teams throughout product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives with particular emphasis on New Product Introduction;
  • To compile, review and approve, as required, regulatory dispatches in accordance with national requirements to ensure appropriateness and consistency in consistency in content and presentation of information both within and between registration applications with particular emphasis on New Product Introductions;
  • To complete the requirements of the Registration Programme as agreed with the AWM and Operations departments;
  • To provide support to the Hull/Suzhou Business Units as and when required;
  • In relation to the above, to interpret individual country legislation relevant to the S&N AWM business;
  • To provide advice and guidance, in an expert capacity, to the AWM RA staff;
  • To liaise with external regulatory authorities to ensure approvals are obtained in line with the launch plan;
  • To review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details;
  • To review and approve change control impact assessments for products;
  • To approve European Technical Files and regulatory dispatches, where appropriate;
  • Deputise for the Regulatory Affairs Managers when required;
  • Ensure compliance to cGMP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820 and any other applicable quality standards or regulations concerning Medicinal Products and Medical Devices;
  • To apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.

Requirements

  • This role will include line management responsibility of 2-3 people, so experience in a similar position is highly desirable;
  • Ideally an honours degree, in a science subject or equivalent;
  • Candidates should be experienced within Regulatory Affairs, preferably within the Medical Devices field;
  • Regulatory experience or equivalent within a regulatory compliance function within a similar environment;
  • Global experience within Regulatory Affairs is highly desirable, including USA and APAC;
  • Good interpersonal skills are essential;
  • Eligibility to work in the UK.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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