Regulatory Affairs Associate - Glasgow

Job Ref: J31865
Sector: Science
Sub-sector: Medical Devices
Job Type: Permanent
Date Added: 20 May 2019
  • Glasgow, Scotland, UK Newmains Avenue Glasgow Glasgow UK PA4 9RR
  • Competitive
    ANNUM
  • Pamela Mackie
  • 0141 847 0319
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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Regulatory Affairs Associate x 2 - Permanent - Glasgow

Are you an experienced Regulatory Affairs professional looking for a new challenge?

OR are you looking to make your first step into a career in Regulatory Affairs?

SRG is recruiting for multiple Regulatory Affairs Associates for a leading medical device manufacturer based in Glasgow.

This is an exciting opportunity for a Regulatory Affairs professional to be responsible for maintaining an awareness and understanding of how activities are performed within the business to achieve quality objectives.

Key Responsibilities:

  • Assist in the production and review of design dossiers technical files, and Product Approval Certificates.
  • Preparation of regulatory submission for product approvals.
  • Preparation of Custom Made device, Special Products paperwork and change assessments.
  • Participate in Design Control, Risk Management, Post Market Surveillance and document changes
  • Facilitate compliance with Vigilance System.
  • Update and review all IFU, Packaging and Labelling.

Qualification, Skills & Experience required:

  • BSc Hons Degree or equivalent
  • Regulatory experience within a medical device or pharmaceutical environment is desirable.

If you are looking for a challenging new role and want to work for a leading medical device company based in Glasgow then this position is for you.

SRG is the UK's number one recruitment company specialising in the scientific, engineering, clinical, pharmaceutical, food/FMCG, energy & renewables, biotech, chemical and medical device sectors.

As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing excellent temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients.

If you would like to apply for this position, please use the link provided.

For more information regarding this position or any others, please contact Pamela.

If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, ethnicity, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Key Words: medical device, ISO 13485, regulatory affairs, FDA CFR 21 820, submissions, product registration, design dossier technical files

SRG
19/06/2019 12:32:48
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