Robert Half International Regulatory Affairs Specialist in Mount Laurel, New Jersey

Description

This role, reporting to the VP of Operations, will sit in the Mt. Laurel New Jersey office and will function as the RA/QA Subject Matter Expert, supporting the US and Canadian Divisions. This individual will have no Direct Reports, but will work closely with all Departments in the company to handle both Regulatory Affairs and Quality Assurance.

RESPONSIBILITIES: * Manage/Lead the 510(k) process from start to submittal * Host FDA Inspections * Function as the Audit Host for Notified Bodies and other Regulatory Agencies including ANVISA, FDA, and Third Party Auditors * Key contributor to FDA IDE Supplements, Amendments, and PMA modules as well as Investigator and Annual Progress reports * Manage and support IDE Change Notice and Supplements, Pre-IDE and Pre-submission notices * Function as the Subject Matter Expert for and during Internal as well as FDA and Health Canada Audits. * Responsible for developing Regulatory strategies and assuring company adherence to FDA and Internal SOP?s * Responsible for Quality Assurance/Quality Systems issues regarding device repair/trending errors/CAPA?s as well as internal reporting, Customer Complaints, Customer and Technical Service issues * Maintain Quality Management System Software * Function as the Point Person for Quality Management System Software Package * Review, approve, and deploy all configuration changes * The role is responsible for all FDA 510(k) filings, FDA Audits, Health Canada filings and compliance, and Internal and External Vendor Audits

Requirements

  • Minimum of a Bachelor?s Degree; Master?s Degree is a plus
  • Experience hosting FDA/Notified Body audits
  • The individual must have experience with the entire 510(k) process from strategy to completion
  • Quality Systems experience; CAPA, Complaints, Trending
  • Experience working in a small to medium sized company
  • Quality experience, specifically with trending errors regarding device issues as well as Internal Reporting regarding Quality issues. CAPA experience is needed as well
  • The individual must be a self-starter with the ability to make decisions and support those decisions
  • The ability to change priorities and the experience to act on changing priorities
  • ?Company first? work ethic
  • Ability to take responsibility for decisions made and the drive to keep up with changes in the Regulatory landscape

For immediate consideration, please email your resume directly to [email protected]

Robert Half Finance & Accounting, the world's leader in specialized financial staffing, provides exciting full-time opportunities in the areas of accounting, bookkeeping, finance, audit, taxation and more. We pioneered the professional staffing industry, and we've been successfully matching professionals with employers since 1948. Our proven proprietary processes, along with our relationships in 325 locations worldwide, allow us to provide you unparalleled access to exciting career opportunities. But don't take our word for it. Our company has appeared on Fortune® magazine’s list of “World's Most Admired Companies” since 1998, and 9 out of 10 of our customers would recommend our service to a colleague.

Apply for this job now or contact our nearest office at 844.539.2523 for additional information.

All applicants applying for U.S. job openings must be authorized to work in the United States. All applicants applying for Canadian job openings must be authorized to work in Canada.

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Salary: $60,000.00 to $70,000.00 per year

Location: Mount Laurel, NJ

Date Posted: December 5, 2018

Employment Type: Full-time

Job Reference: 02700-0010757660

Staffing Area: Full-Time Accounting & Finance