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Regulatory Affairs specialist

TemplarFox Consultancy
Posted 18 hours ago, valid for 7 days
Location

Huddersfield, West Yorkshire HD5 8XT

Contract type

Full Time

In order to submit this application, a Reed account will be created for you. As such, in addition to applying for this job, you will be signed up to all Reed’s services as part of the process. By submitting this application, you agree to Reed’s Terms and Conditions and acknowledge that your personal data will be transferred to Reed and processed by them in accordance with their Privacy Policy.

Sonic Summary

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  • My client, a leading regulatory consultancy based in Yorkshire, is seeking to recruit a medical devices Regulatory Affairs professional on a permanent basis.
  • The role requires proven experience in the regulated medical devices industry, specifically in QA, Regulatory Affairs, and knowledge of MDR regulations.
  • Candidates should have a degree in life sciences or a related STEM subject and experience in post-market surveillance and regulatory submissions.
  • The position involves compliance and diligence of technical product files and liaising with regulated bodies, with a salary of £40,000 to £50,000 per year.
  • Applicants must be legally entitled to work in the UK and demonstrate relevant experience in quality systems and supplier management.

My client, a leading regulatory consultancy based in Yorkshire are expanding and looking to recruit a medical devices Regulatory Affairs professional on permanent basis. The role will be based on site.

You will be responsible foro Responsible for compliance and diligence of product technical product fileso Provide and support advice and technical updates in Medical Device Regulations (MDR) - Class 2 & 3. o Liaise with regulated bodies - submissions, queries and clarity. o Compile and control product technical files for all new MDR product registrationso Review compliance and update existing product technical files. o Experience in Post Market Surveillance PMS, collation, review and writing o Provide input and support to site leadership and business direction

To be considered for a role in Regulatory Affairs, you should possess the following:

• Proven experience in the regulated environment Medical devices industry in QA, Quality Assurance and RA Regulatory Affairs.

• Previous industrial experience of MDR, regulatory submission, project management, quality supplier auditing, Quality systems(QMS)• Knowledge/experience of relevant legislation MDR• A degree in life science, STEM or related subject

Key Words: QA, Quality Risk Management, Quality Systems, Supplier Management, Audits, regulatory affairs, ISO13485, BRC, HACCP, Compliance, technical files, MDR,

If you believe you hold the relevant background experience and looking for a new role as RA Specialist within this independent successful and growing business then this is the role for you.

About us: Templarfox is a privately owned recruitment business leading in executive search, management selection, Salary benchmarking and Business development services. The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency.

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In order to submit this application, a Reed account will be created for you. As such, in addition to applying for this job, you will be signed up to all Reed’s services as part of the process. By submitting this application, you agree to Reed’s Terms and Conditions and acknowledge that your personal data will be transferred to Reed and processed by them in accordance with their Privacy Policy.