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Senior Quality Assurance & Regulatory Affairs Specialist

TEC PARTNERS LIMITED
Job LocationCambridge
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Senior Quality Assurance & Regulatory Affairs SpecialistThis brand new, challenging and exciting role will afford you the opportunity to join a leading R&D organisation in the Cambridge area. The Quality & Regulatory team enables innovation for their customers by collaborating with and guiding the business to achieve quality and regulatory compliance in a rapidly changing environment.The role:- Provide company-wide quality and regulatory expertise to various project teams, both medically and non-medically focused projects.- Support the QA Manager and Head of RA with operational duties of the QMS.- Bring expertise in the regulatory field which you should wield to provide strategic advantages to client projects across various geographical regions- Lead communication regarding key changes in regulations and interpret their impact on projects and the wider business- Work effectively to demonstrate your project management and leadership skills to facilitate project work. Internal initiatives and communication is also essential to have a contribution across the wider business- Find pragmatic and effective solutions to regulatory issues that may arise in projects, to achieve all key measurable objectives without compromising on design processesWhat you will bring to the role:

  • Extensive experience in Quality and Regulatory functions, ideally within Medical Technology (other highly regulated backgrounds will be considered)* In depth knowledge of global ISO regulations, ideally ISO9001/13485 and 21CFR 820* Track record of being dynamic, flexible and working effectively across multiple projects* Working knowledge of the application of risk management protocols* Degree educated in a relevant discipline* Able to understand and analyse complex problems, which may including software and hardware design issues* Demonstrated ability to collaborate with the business and effectively interact with and influence employees, and managers on all levels* Strong Project Management skills* Excellent written and verbal communication skills
    • This role represents a unique opportunity to join a recognised R&D Organisation that are moving in the right direction, with a range of exciting and innovative projects. This role comes with a highly competitive salary, and a host of benefits in addition to this.If you are interested, please dont hesitate to get in touch with Jamie at TEC Partners, as this role is unlikely to be around for long!

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