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International Regulatory Affairs Manager

Employer
Hyper Recruitment Solutions
Location
Basingstoke
Salary
Industry Competitive
Closing date
9 Apr 2019

Job Details

A new opportunity for an experienced Regulatory Affairs professional with a focus on Medical Device strategy at an International level has become available to join a Global Life Sciences company. This position is located in the South of the UK and can be based from any of their offices in Hampshire, West Sussex or Kent.

This is a senior level position with line management responsibilities. As the International Regulatory Affairs Manager you will be expected to lead the International strategy for IVD and Medical Devices. You will influence internal stake holders and ensure the successful submission of novel licences.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Line Management - You will lead a small team of Regulatory Affairs professionals focused on increasing the market access of clinical diagnostic products through successful pre-market licences. You will ensure that your team follow company strategy in an accurate and timely manor.

2. Strategy - You will assist with the development and execution of Internationally focused strategy for IVD (In-Vitro Diagnostic) Medical Devices. Regions will include the EU, US and Asian markets. By generating regulatory intelligence and using your product knowledge and understanding of technical data, you will ensure the successful submission of licences to a range of markets.

3. Life Cycle Management - You will ensure that existing Global product licences are maintained through the timely submissions of Variations and Renewals.

4. Collaboration - You will work cross-functionally with a range of departments including R&D and Commercial teams and will influence internal and external stakeholders and key opinion leaders.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Life Sciences Discipline (e.g. Biology; Biotechnology; Chemistry; Medical Device focused degree etc.) in additional to extensive International Regulatory Affairs experience within Medical Devices or IVD industry.

2. Proven industry experience in leading a team of Regulatory Professionals where you are ensuring KPIs are met and important project timelines are maintained.

3. A working knowledge and practical experience with International Regulatory Affairs Strategy development for Medical Devices or IVDs.

Key Words: Regulatory Affairs | Medical Devices | In Vitro Diagnostics | IVD | IVDs | Strategy | CE Marking | Global | International | Regulatory Intelligence | Clinical Diagnostics |

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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