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Director Regulatory Affairs - Combination Products

Employer
Hyper Recruitment Solutions
Location
London
Salary
Competitive
Closing date
9 Dec 2019

Job Details

Hyper Recruitment Solutions have teamed up with a growing Global Biotechnology company to identify an experience Regulatory professional with exposure to Combination Products to join them as Director of Regulatory Affairs. As the Director Regulatory Affairs you will be responsible for all Regulatory activities relating to In-Vitro Diagnostic ( IVD ) Medical Device products.

You will report directly to the VP of Regulatory Affairs and lead the development of Global Regulatory strategy for diagnostic products that aligns with the commercialisation of Cell and Gene Therapy products.

This position is a fantastic opportunity to join a developing company where you will have the opportunity to build a team around yourself to influence the successful commercialisation of ATMPs.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Director Regulatory Affairs - Combination Products will be varied however the key duties and responsibilities are as follows:

1. Develop Regulatory strategy for diagnostic IVD products to assist with the commercialisation of Cell and Gene Therapy products. You will develop strategy for both EU and US markets and act as the internal subject matter expert for Combination products.

2. Manage Regulatory activities for Medical Device submissions including but not limited to CE Marks, EU/US Premarket Approvals ( PMAs ), 510(k)s, post approval reports and registration and device listings.

3. Act as lead and main point of contact for Regulatory Authorities such as the CDRH (part of FDA), CLIA and Notified Bodies.

4. Maintain technical files as well as keeping up to date Regulatory changes to ensure the internal leadership team and stakeholders as informed.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Director Regulators Affairs - Combination Products 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, Medical Devices, Engineering etc.) in addition to extensive Regulatory Affairs experience of Medical Device products, ideally IVDs.

2. Proven industry experience in working with EU markets where US exposure is a benefit where you have lead the submission of CE-Marking, clinical trial notifications, IDE, 510(k) and PMA submissions. Knowledge of IND, BLA, CTA and MAA submissions is beneficial.

3. A working knowledge and practical experience with of leading a team is beneficial where you have line manage staff directly or through project management. Experience of budget management is preferred but acting as a lead on projects where you have directly liaised and lead meeting with Regulatory bodies and authorities is vital for this role

Key Words: Regulatory Affairs | Director | Lead | Medical Devices | Combination Products | Companion Diagnostics | IVD | In Vitro Diagnostics | EU | US | FDA | EMA | Notified Bodies | CE Marking| 510(k) | PMA | Submission | Strategy | ATMP | Cell Therapy | Gene Therapy

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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