Sr. Regulatory Affairs Specialist
- Job Title
- Sr. Regulatory Affairs Specialist
- Job ID
- Frisco, TX
- Other Location
Senior (Sr.) Regulatory Affairs Specialist, Frisco, TX.
We’re hiring for a Sr. Regulatory Affairs Specialist for our Regulatory Affairs Department at our Global Headquarters in Frisco, TX.
Job Description: The Sr. Regulatory Affairs Specialist will be responsible for authoring regulatory submissions and technical files in both the US and OUS. This regulatory professional will also be responsible for organizing regulatory information including tracking and controlling submissions. This role will participate in product development teams and provide advice on regulatory compliance with 510(k)s.
The 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 provide guidance and advice to colleagues. This regulatory professional will participate in all company regulatory compliance activities.
Sr. Regulatory Affairs Specialist Education and Experience Requirements:
- 5+ years of 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 authoring and 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, Canadian license applications, and preparing and submitting OUS license applications. This individual must possess an awareness of expiration dates of licenses and ensure renewals are submitted on time. This regulatory professional will ensure Argon's regulatory files/database and chronologies are in good order. This role will work to establish and maintain systems for tracking changes in documents submitted to agencies or partners including reviewing changes to existing products and SOPs. The Sr. Regulatory Affairs Specialist will provide the regulatory reviews of customer complaints to determine if events are 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
- 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