Regulatory Affairs Associate in Maplewood, MN at Volt

Date Posted: 7/28/2020

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Maplewood, MN
  • Job Type:
  • Duration:
    48 weeks
  • Date Posted:
    7/28/2020
  • Job ID:
    239155
  • Contact Name
    Volt Branch
  • Phone
    913-201-4928

Job Description

Regulatory Affairs Associate

12+mths

Saint Paul-$37.00 hr

Volt Technical Resources has an opening for a Regulatory Affairs Associate with a well known medical device manufacturer in their Saint Paul, MN Facility.

Description:

This Regulatory Affairs position focuses on assisting with EU MDR readiness of regulatory product files. The candidate will represent the Regulatory Affairs team in a cross functional setting and demonstrate strategic thinking to identify and resolve technical file gaps and assist in developing sound strategies to achieve MDR compliance. This candidate may assist with US and Global International submissions, and complete engineering change orders as needed.

Job Description

  • Prepares robust regulatory applications or technical file documentation to achieve departmental and organizational objectives and support EU MDR transition activities.
  • May act or assist as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.  Provides guidance and expertise.
  • Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.   
  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
  • Reviews protocols and reports to support regulatory submissions.
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

General Qualifications

  • BA or BS degree (degree in a technical discipline highly preferred).
  • A minimum of 5 years of technical experience, including at least 2 years of regulatory experience in a medical device industry.
  • Experience with Class II, III medical devices; EU dossiers/Technical files and FDA applications (510(k), PMA supplements); EU device regulations and experience with US and other international medical device submissions.
  • Strong verbal and written communications with ability to effectively communicate and present Regulatory strategies at multiple levels in the organization.

Volt is an Equal Opportunity Employer