Regulatory Affairs Project Leader in Pleasanton, CA at Volt

Date Posted: 5/20/2020

Job Snapshot

  • Employee Type:
    Contingent
  • Job Type:
  • Duration:
    24 weeks
  • Date Posted:
    5/20/2020
  • Job ID:
    230038
  • Contact Name
    Volt Branch
  • Phone
    919-782-7440

Job Description

Volt Workforce Solutions is looking for a Regulatory Affairs Project Leader for our client, a leader in the Medical Device and Healthcare industry. After reading the job info below, if interested, email an updated resume (in Word format).
After applying to this Job using the Apply or Apply Now button, you can follow up on your application by calling our Enterprise Delivery Center at (800.595.8658) or texting at 916-970-4122. Be sure to note the Job ID number found on this page and reference it when calling about the position.
Job Title: Regulatory Affairs Project Leader
Reference ID: 230038
Location: Pleasanton, CA
Responsibilities:
• Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.
• High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.
• Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.
• Ability to manage and track broad and strategic projects.
• Ability to communicate effectively in writing crisp briefings and issue analysis.
• Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.
• Responsible for effective communication of regulatory requirements to project teams and internal customers. 
• Work with Subject Matter Experts (on EST) to close gaps for Medical Device Regulations (MDR)
Qualifications
• Bachelor’s required.
• Prior regulatory experience in the medical device required.
• Class II Medical Device experience required.
• Need strong technical background in science or engineering.
• 3+ years handling Regulatory submissions.
• Needs excellent submission writing skills.
• Technologically strong and capable.
• Background with either Premarket Approval Applications (PMA) or 510K.
• Capability to work remotely until office reopens 
As a Volt employee, you can expect the highest level of support.  We have a long-standing tradition of developing lasting and mutually beneficial relationships with our employees.  Contact a Volt representative by applying to this posting online for immediate consideration. Submit your resume today!
To learn more about Volt, please visit: http://www.volt.com and to see more of our job postings, please visit: http://jobs.volt.com
Volt is an Equal Opportunity Employer.