Job Openings

Regulatory Affairs Specialist III

Recruiter Nancye Claxton (nclaxton@psgi.net)

Memphis, TN

ProTech is seeking a Regulatory Affairs Specialist IV for a contract opportunity for our client in Memphis, TN.

Position Overview:

Supports in the generation of Technical Files and Design Dossiers. Works with cross functional teams to deliver supporting documentation (IFU, DHF, CER etc.).  Supports and implements the global market change program.  Demonstrates strong understanding of MDR requirements.  Supports Technical File Audits Line Management of RA.  Assists with preparing and communicates submission/compliance strategy document.  Reports compliance metrics to the RA Franchise lead/Manufacturer Lead and works with the RA Franchise lead/Manufacturer lead to plan and deliver submissions to specified time frames. Prepares and reviews technical documentation including labeling and instructions for use and works with relevant team to resolve issues.  Post finalized technical documentation to central repository.  Communicates changes to global markets and provides submission deliverable. Prepares for and assists with Notified Body technical audits; responds to any deficiencies Minimum 3 years Regulatory experience within the Medical Device industry. Good interpersonal/communication skills are essential. Experience of providing Regulatory Advice to the business is essential. Ability to handle multiple demands in a fast-paced environment.  

Essential Duties and Responsibilities:

  • Prepare global regulatory submissions such as 510(k), PMA, for new and modified devices. 
  • Work closely with teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in US market. 
  • Communicate with FDA regarding submissions. 
  • Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements. 
  • Review package inserts (labeling) and promotional materials to insure compliance with FDA requirements. 

Education and Experience Requirements:

  • Bachelor’s or Masters’ degree in Engineering or life sciences preferred, but other degrees may be considered. 
  • The candidate should have a minimum of 3 years of regulatory submissions experience in the medical device industry specifically with US FDA submissions. Wound, and reconstructive device experience is desired. 
  • Extensive knowledge of FDA regulations required. 
  • Minimum 3 years Regulatory experience within the Medical Device industry.
  • Good interpersonal/communication skills are essential.
  • Experience of providing Regulatory Advice to the business is essential.
  • Ability to handle multiple demands in a fast-paced environment.  

Desired Skills:

  • Excellent English written and verbal communication skills including presentation skills, Microsoft Office application skills, self-motivated, attention to detail, able to prioritize and manage multiple projects. Able to lead projects with minimal supervision.
  • Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology and complex documents. 
  • Ability to respond to inquiries and complaints from customers and regulatory agencies. 
  • Ability to write detailed technical regulatory submissions, reports and business correspondence. 
  • Ability to effectively present information to other employees, management and regulatory agencies. 
  • Ability to compute ratio, percent and draw and interpret raw data into graphical representations.
  • Ability to convert English units into metric units and vice versa. 
  • Ability to comprehend and apply principles of algebra, statistics, calculus and mathematical operations used in various engineering and clinical analysis. 
  • ISO auditing or RACS preferred