Regulatory Affairs Officer

Key People


Job ID :

8033


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Kent,Dartford,


Key Skills :

Regulatory Affairs. Medical Devices.


Salary :

Negotiable


Date Posted :

27 Jul, 2017



Company Name :

Key People


Location1 :

Dartford




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Key Responsibilities:

* Be the primary RA representative for the Immunodiagostics products for which Dartford has responsibility as well as RA responsibility for distribution activities of other MBD products that are distributed from the Dartford site
* Develop and deploy global regulatory strategies and manage the pre-market submission of the Immunodiagostics products as well as assist with the registration of Dartford-distributed products as necessary
* Act as the lead RA within a cross-functional project team, providing inputs into New Product Development, changes to existing products and other activities involving the complete life-cycle management of products
* Be responsible for the planning and implementation of new and updated regulations as applicable to Dartford products while working in coordination with global regulatory affairs
* Assist Line Manager in gathering relevant KPI and metrics
* Lead change projects and site quality review meetings
* Minimum Requirements/Qualifications:
* Bachelors or Masters degree in Science preferably in the Biological Sciences or Regulatory Affairs
* Proven experience in regulatory affairs in IVD or medical devices companies. Regulatory Affairs Certified individual preferred.
* Ability to make balance decisions in relation to business/customer requirements and offer appropriate advice
* Ability to work with minimal supervision with sound technical judgment and analytical skills in a highly matrixed business environment
* Ability to coordinate and manage the completion of multiple projects simultaneously
* Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
* Multitasks, prioritizes and meets deadlines
* Strong organizational and follow-up skills, as well as attention to detail
* Ability to travel within UK and internationally as required
* Non-Negotiable Hiring Criteria:
* Proven experience in RA in IVD or medical devices companies
* Experienced in submission or Technical File compilation
* Strong project management and organisational skills
* Demonstrated experience in navigating complex pre-market submissions.
* Experience working in a broader enterprise/cross-division business unit model preferred

*IND-EMEA


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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