Regulatory Quality Control Specialist 1/23/2020

Yoh Hazelwood, MO

Company
Yoh
Location
Hazelwood, MO
AJE Ref #
586459253
Job Classification
Full Time
Job Type
Regular
Company Ref #
244866
Experience
Mid-Career (2 - 15 years)
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
REGULATORY QUALITY CONTROL SPECIALIST needed for a contract to hire opportunity with Yoh Scientific's client located in ST. LOUIS, MO area. The client is a multinational biotechnology company founded and headquartered in France. If you meet the requirements, please send me a Word copy of your resume to kelly.hua@yoh.com.

POSITION SUMMARY:

Responsible for the evaluation, coordination, preparation and execution of Regulatory and Quality Compliance policies, procedures and strategies regarding Field Actions, Vigilance Reporting, Post Market Surveillance, and Corporate QMS Indicators.

PRIMARY DUTIES:

* Evaluate complaints and determine if Vigilance Reporting requirements apply within regulatory time lines. Complete applicable vigilance records and obtain manager approval (MDR, Incident, Biologics, and Accidental Radiation Occurrence).

* Monitor and maintain familiarity with applicable regulations, and assist with the review and revision of procedures accordingly.

* Create and manage the completion of the Post Market Surveillance (PMS) reports as assigned.

* Create complaints from scientific publication review for PMS.

* Assist sites in the completion of the Corporate QMS indicators and definition of the action plans.

* Assist in the execution and improvement of regulatory processes and interaction with regulatory agencies.

* Participate and support audits and inspections as assigned.

EDUCATION:

* Minimum of a Bachelor's degree

* Must have 2+ years investigation experience

* Must haves investigation writing or report or technical writing.in Microbiology

* Regulatory experience preferred

* Clear communication skills.

* Work well with others/ cross function.

* Represents our group! Be adaptable.

#ESNALS

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here:
http://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.