Regulatory Project Manager - Science sector

  • Job Reference: 00023126-1
  • Date Posted: 14 October 2020
  • Recruiter: CV-Library
  • Location: Ashford, Kent
  • Salary: £50,000 to £60,000
  • Sector: Healthcare & Medical, Science & Technology, Covid-19
  • Job Type: Permanent

Job Description

JOB TITLE: Regulatory Project Manager

LOCATION: Ashford

SALARY: £50k-£60k

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:

This is a new key operational 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 organisationsREQUIREMENTS:

An understanding of EU medical regulatory requirements is essential
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 changeINTERVIEW 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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