Careers

Sr. Regulatory Affairs Specialist

Job Title
Sr. Regulatory Affairs Specialist
Job ID
27355561
Location
Frisco,  TX
Other Location
Description

Senior (Sr.) Regulatory Affairs Specialist, Regulatory Affairs, Fulltime, Frisco, TX

We’re hiring for a Senior (Sr.) Regulatory Affairs Specialist for our Regulatory Affairs Department in a fulltime capacity at our Frisco, TX location

Senior (Sr.) Regulatory Affairs Specialist: The Sr. Regulatory Affairs Specialist will be responsible for authoring regulatory submissions and technical files in both US and OUS. The Sr. Regulatory Affairs Specialist will also be responsible for organizing regulatory information and tracking and controlling submissions. The Sr. Regulatory Affairs Specialist will participate in product development teams, review and advise on labeling for compliance with regulatory filings including 510(k)S.

Sr. Regulatory Affairs Specialist will be responsible for reviewing and approving product changes for impact on regulatory filings worldwide and will research all regulatory issues to be able to provide guidance and advice to colleagues and participate in company regulatory compliance.

Senior (Sr.) Regulatory Affairs Specialist: Education and Experience Requirements

  • 5+ years relevant experience in FDA regulated industry – US Class II products and higher
  • Bachelor of Science or Arts in a related field required
  • Regulatory Affairs Certification (RAC) preferred
  • Knowledge of US and international medical device regulatory requirements
  • Experience with submitting 510(k)s is mandatory
  • Strong understanding of design controls

The Sr. Regulatory Affairs Specialist will be responsible for writing US 510(k)s, drafting European technical files and Canadian license applications as well as prepairing and submitting OUS license applications. The Sr. Regulatory Affairs Specialist must possess awareness of expiration dates of licenses and ensures renewals are submitted on time including mmaintaining regulatory files/database and chronologies in good order. The Sr. Regulatory Affairs Specialist will work to establish and maintain systems for tracking changes in documents submitted to agencies or partners including Review changes to existing products and SOPs to define the requirements for regulatory submissions. The Sr. Regulatory Affairs Specialist will provide the regulatory reviews of customer complaints to determine if event is reportable.

Argon Medical is a global manufacturer of specialty medical products including a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. With over 800 employees worldwide. Argon has manufacturing facilities located in Athens, TX, Wheeling, IL and Rochester, NY.  Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. https://www.argonmedical.com/about/our-company

If you are interested in hearing more about this Senior (Sr.) Regulatory Affairs Specialist role contact a recruiter today at Andrew.Foran@argonmedical.com or apply online www.argonmedicaljobs.com

Required Skills

Senior (Sr.) Regulatory Affairs Specialist: Education and Experience Requirements
• 5+ years relevant experience in FDA regulated industry – US Class II products and higher
• Bachelor of Science or Arts in a related field required
• Regulatory Affairs Certification (RAC) preferred
• Knowledge of US and international medical device regulatory requirements
• Experience with submitting 510(k)s is mandatory
• Strong understanding of design controls

Option 2: Create a New Profile