Sr. Regulatory Affairs Specialist - Contract to Hire

Location: Dallas, Texas Salary: US$80000 - US$95000 per annum + competitive
Sector: Regulatory Affairs, Quality Assurance (QA), Regulatory Affairs (RA) Type: Contract

An innovative medical device company focused on aesthetics products is looking for a Sr. Regulatory Affairs Specialist due to a large growth initiative.

The Regulatory Affairs Specialist will have the following responsibilities

  • Develop and manage global regulatory strategies to maximize the value of the products/projects
  • Manages the U.S. FDA Class II medical device submissions
  • Global responsibilities for device registrations, supports medical device registrations in Rest of World
  • Supports ISO audit to maintain ISO 13485:2016 certification, MDSAP, FDA, TGA, and Health Canada, audits (and others)
  • Responsible for EU Medical Device Directive 93/42/EEC and Class I, IIa, and IIb medical devices, transition to MDR
  • Responsible for all updates to tech files.
  • Assists the Medical Affairs department with documentation
  • Supports all the regulatory aspects of the product lifecycle, Post Market Surveillance
  • Yearly establishment registration and device listing updates and renewals
  • Ensures awareness of and compliance with global regulatory requirements and adherence to internal policies and processes
  • Provides solutions to a range of regulatory issues and creates plans to execute
  • Provides high quality regulatory support for assigned products/projects
  • Partners with internal and external stakeholders to align on an optimized regulatory strategy to achieve business objectives.
  • Develops documents that are clear, concise, and complete to facilitate reviews/approvals

This is a 6 month contract to hire position.

Sthree US is acting as an Employment Business in relation to this vacancy.