Regulatory Quality Control Specialist 1/23/2020
JOB DESCRIPTIONAPPLY 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 email@example.com.
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.
* 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.
* 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.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here:
to contact us if you are an individual with a disability and require accommodation in the application process.