Regulatory Affairs Specialist - Science sector

JOB TITLE: Regulatory Affairs Specialist - Science sector



LOCATION: Ashford



SALARY: £45k-£55k



CULTURE & BENEFITS:


Modern, forward thinking, evolving, extremely successful business with a flexible working approach - you won't be micro managed, you can work 8am-4pm, 8:30am-4:30pm or 9am-5pm for example, free parking, 20 days annual leave plus bank holidays and often company lunches on a Friday



ROLE SUMMARY:


A new key role ensuring the necessary Technical input to ensure the products meet all necessary global regulatory requirements. Working as necessary with Sales, Finance and Supply Chain to ensure the optimum introduction of new products and supply to international house accounts.



RESPONSIBILITIES:



  • Management of Technical Project Executive (we're recruiting for this role so we'll introduce the best candidate for you 😊)

  • Maintenance and development of the Technical Files

  • Liaison with Quality Manager and external consultants to ensure compliance of QMS with ISO 13485

  • Liaison with Sales to review feasibility of new product proposals

  • Liaison with Sales to prepare new product specification

  • Liaison with Supply Chain to ensure margin expectations are being met, negotiating as necessary to achieve target

  • Introduction of new SKU's to international buyers and management of process through to receipt of P.O. including negotiation of payment terms

  • Liaison with export regulatory bodies and customers to ensure preparation and supply of necessary regulatory documentation and compilation of Product Technical Files

  • Preparation and management of all necessary manufacturing validation protocols

  • Management of new product introduction to manufacturing facility

  • Liaison with contract manufacturing organisations



REQUIREMENTS:



  • An understanding of EU regulatory requirements

  • Experience in the preparation of regulatory documentation

  • Project management experience

  • Commercially aware

  • Degree level qualification (or equivalent) in a relevant science subject

  • Excellent attention to detail

  • Demonstrable strong Communication skills across all levels internally & externally

  • Organised and capable of prioritising and dealing with change



INTERVIEW PROCESS:


2 stage, on site (or via MS Teams if you prefer), our client is adhering to strict, COVID-19 safety measures


NEXT STEPS:


Apply today, our client can interview immediately, we look forward to receiving your application.

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To speak to a recruitment expert please contact Bonnie Dolan