Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistWant to apply? Read all the information about this position below, then hit the apply button.- EMEA- 12 Month Contract My client, a leading Medical Device manufacture has a requirement for an experienced senior Regulatory affairs specialist to join their EMEA Regulatory team based in Witney, Oxfordshire.This role is a 12 month contract with the possibility of extension.As Regulatory Affairs Specialist, you will be responsible for: Assisting in the direction of development of product registration submission, progress reports, supplements, amendments, or periodic experience reports Interact with Regulatory Agency to gain product approval or expedite pending registrations Regulatory liaison throughout product lifecycle Involved in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.Advises development and marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations To be considered for the position of Senior Regulatory Affairs Specialist, you will: Have at least 5 years relevant experience in a similar role Medical Device or Invitro-diagnostic experience Educated to degree level in a relevant Scientific field Randstad CPE values diversity and promotes equality.No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010.We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.Candidates must be eligible to live and work in the UK.For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.

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