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Clinical & IVD Regulatory Strategy Leader - Immuno Assay Focus

Employer
NonStop Consulting
Location
North East England
Salary
Negotiable
Closing date
Mar 28, 2019

View more

Sector
Science, Life Sciences, Evolution
Contract Type
Employee
Hours
Full Time
Organization Type
Clinical Practice

Job Details

NonStop Recruitment are currently partnered with a leading in-vitro diagnostic solution provider to source a Head of Clinical & Regulatory Affairs.

Benefits:

- Young and dynamic company/industry

- Company currently enjoying heavy investment

- Lovely environment with family culture

- Senior management role


Additional benefits include:
* 22 days holiday with the option to purchase an additional 5 days
* Life Assurance x 2 salary
* Free onsite parking
* Monday to Friday
* Private medical insurance
* Discount at local gym

Due to an increase in company pipeline, this company are seeking a senior Manager to head up both their Clinical & Regulatory teams.

You will be leading a team consisting of 3 managers, with further staff under them, as you collaborate with senior Directors on matters of strategy, and Regulatory & Clinical approach and policy.

Overseeing a broad portfolio of innovative Diagnostics, you will be able to work with cutting edge solutions for the clinical laboratory market.

Requirements:

- Masters Degree or PhD in related scientific subject (Chemistry, Biochemistry, Biomedical Science)
- Qualification in RA Discipline desirable

- Very strong working knowledge of premarket registration particularly in Europe (IVDD and IVDR), the US, and China for IVD diagnostic devices; and particularly for autoimmune, infectious disease, allergy, and specialty endocrinology devices.
- Knowledge and experience of Quality Management Systems, e.g. ISO13485 and the US Quality System Regulation
A strong working knowledge of applicable regulatory requirements for IVDs. At minimum FDA Code of Federal Regulation. European, Canadian Medical Device Regulations, BRIC and ASEAN country regulations desirable but not essential.
- A strong working knowledge of applicable performance requirements for IVDs particularly the applicable CLSI guidelines. Ability to interpret and evaluate statistical performance data for an IVD device.
- A good working knowledge of the clinical evaluation/performance requirements for IVDs particularly autoimmune and infectious disease devices.

For a confidential discussion about this, please contact Edward Little on 0207 940 2749 (EXT: 7168) or send your updated CV in a word document to E.Little@nonstop-recruitment.com

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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