Regulatory Affairs Officer

Key People

Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

United Kingdom,Kent,Dartford,

Key Skills :

Regulatory Affairs. Medical Devices.

Salary :


Date Posted :

27 Jul, 2017

Company Name :

Key People

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



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


Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom





less than 100




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.

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