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Regulatory Affairs Advisor

Employer
Hyper Recruitment Solutions
Location
Cambridgeshire
Salary
Dependent on Experience
Closing date
5 Jun 2019

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Job Details

A exciting opportunity for a Regulatory Affairs Assistant has become available in a leading Medical Device company based just north of Cambridgeshire. As the Regulatory Affairs Assistant you will support regulatory submission through the co-ordination and maintenance of Regulatory files including DMFs, 510(k), Technical Files MAF and site Master files.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Regulatory Affairs Assistant will be varied however the key duties and responsibilities are as follows:

1. Complete, maintain, own and deliver all regulatory documents, e.g. MHRA licences, DMF etc. as well as maintaining drug and device registrations with the FDA to ensure they are up to date to enable the company to continue supplying product to the US market.

2. Work closely with Regulatory Agencies including the MHRA, FDA and Canada Health. You will assist with customer visits, audits and Regulatory Authority inspections.

3. Provide direction, advice, training and guidance to employees regarding compliance and regulatory issues, including the review and implementation of QMS transactions (notifications, change controls etc.).

4. Maintain up-to-date knowledge of relevant regulatory legislation and guidelines specific to the company's new and existing programmes to ensure regulatory requirements are compliant and continuous improvement in Regulatory Affairs processes and procedures.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Regulatory Affairs Assistant we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline e.g. Biology, Chemistry, Pharmacology, Pharmacy etc. in addition to prior Regulatory Experience from current position or industry placement.

2. Knowledge of EU and USA Regulatory Filing process for medicines and/or Medical Devices.

3. Proven ability to work in a face paced environment where you have worked accurately with excellent organisational skills; managing time and adapting when necessary.

Key Words: Regulatory Affairs | Assistant | Associate | Officer | Medical Device | Combination Drug Products | DMF | 510(k) | Technical Files | Master files | MHRA | FDA

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

Company

Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.

Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.

Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.

We provide services across a broad range of industries including the following specialist sectors:

• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science

With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:


• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability 
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments


HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.

Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com


Or any of the social media routes below: 
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Company info
Website
Telephone
0203 910 2980
Location
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB

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