Senior Regulatory Specialist

  • Location
    Ripon, North Yorkshire
  • Salary
    £ 45000 - £ 60000 / Year
  • Job type
    Permanent
  • Industry
    Manufacturing and Production
  • External Reference
    456871
  • Category
    Engineering, Aerospace, Automotive - Manufacturing & Production Engineering

Title: Senior Regulatory Specialist


Location: Ripon (2 days onsite per month, the rest remote)


Contact:


Adecco Lifesciences are representing a Medical Device business with over 20 years of experience in the design and manufacture of high-class products.


With a solid reputation in the market, the consistency of delivery and service paves the way for repeat business time and time again.


Selling products in over 50 countries under world-renowned brands, the business is going from strength to strength.


This is a fantastic opportunity to join a company and a team with a close-knit working culture, a passion for quality and regulatory, and the support to inspire their employers to reach their full potential.



The Opportunity:


In this role as Senior Regulatory Specialist, you will have the chance to work alongside a motivated team to create technical documentation for new product developments and remediate existing technical files to ensure MDD to MDR compliance.

This will be an opportunity to support the business in a range of regulatory activities including global product submissions with a particular focus on the US and creating regulatory plans for NPD.


Requirements:


As a Regulatory Specialist you will (not an exhaustive list):



  • Create and maintain technical files of all legal manufactured products

  • Update Technical files to meet requirements of MDR, US FDA and CE marking and ongoing business needs

  • Assist in preparing responses to regulatory authorities' questions within assigned timelines.

  • Create regulatory plans for the design and development teams to support Global markets

  • Update standard operating procedures and templates as relevant.

  • Support external regulatory agency audits, providing regulatory input to minimise the potential for findings of non-compliance



Background needed:


5+ years of Regulatory experience in the Medical Device industry


Working Knowledge of US FDA requirements, EU Medical Device regulations, harmonised


standards and associated non-harmonised standards


Knowledge of Canadian regulations and MDSAP is desirable but not essential


Interested in a further conversation?


Please apply to this advert or also send your CV to arrange a confidential career discussion.


Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

To speak to a recruitment expert please contact Amy Holder