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Regulatory Affairs Specialist - Science sector

Employer
Office Angels
Location
Ashford, Kent
Salary
£45000 - £55000/annum
Closing date
2 Dec 2020

View more

Job Sector
Science
Contract Type
Permanent
Hours
Full Time
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.

Office Angels acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. Office Angels UK is an Equal Opportunities Employer.

By applying for this role your details will be submitted to Office Angels. Our Candidate Privacy Information Statement explains how we will use your information - please copy and paste the following link in to your browser

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