Careers

Regulatory Affairs Manager U.S. Submissions

Job Title
Regulatory Affairs Manager U.S. Submissions
Job ID
27418147
Location
Frisco,  TX 75034
Other Location
Description

Regulatory Affairs Manager U.S. Submissions, Frisco, TX.

We are hiring for a Regulatory Affairs Manager U.S. Submissions to join our Regulatory and Quality Department at our Frisco, TX headquarters.

Job Description: The Regulatory Affairs Manager will manage complex issues with multiple competing priorities, directly impacting site operations and commercial opportunities. Develop strategies for US/FDA governmental approval to introduce new products to market, provide advice on regulatory requirements, support development of worldwide submissions, and facilitate their approval. This individual will work to manage regulatory problems related to development, manufacturing, and commercialization and recommend action to senior leadership to ensure effective resolution will be required.

The Regulatory Affairs Manager will be responsible for coordinating, preparing, and managing all USA/FDA regulatory submissions, supplements, certification including IDE, 510K, and PMA. This regulatory professional will Act as an Argon representative, developing and maintaining a positive relationship with U.S. FDA reviewers through oral and written communications on pre-submission strategy, regulatory pathway development, testing requirements, clarification, and follow-up submissions under review. Other responsibilities will include oversight of the creation and maintenance of associated technical documentation for USA-registered products.

 Regulatory Affairs Manager U.S. Submissions Education and Experience Requirements:

  • Bachelor's Degree in science, math, or engineering discipline. An advanced degree is preferred
  • Certification: RAPS (RAC or RAC-US)
  • Ten years of work experience in U.S. Regulatory Submissions including experience as a regulatory team member on New Product Development Teams participating on at least ten (10) FDA 510(k) submissions required, with submission lead experience for at least three (3) submissions; OR, experience as a regulatory team member for three (3) FDA PMA submissions.
  • IDE support, review, and defense are required. Experience in pre-submission/Q-Sub meetings with FDA preferred
  • Prior experience interfacing with the FDA during inspections and technical presentations
  • IEC 60601 and eQMS experience preferred

The Regulatory Affairs Manager will participate in Notified Body/FDA or other third-party audits. This individual will be responsible for preparing evidence of Quality System compliance as required by Corporate RAQA or regulatory agencies.  Review and approve scientific and promotional materials and documentation change requests to ensure regulatory compliance in accordance with Argon's policies and procedures. It will be the responsibility of this Regulatory Manager top to provide regulatory guidance to support Argon R&D's efforts in the development and design of new/modified products to your global counterparts within Argon. Other responsibilities will include maintaining and updating documentation according to Argon Company procedures, standards, and regulatory requirements. The Regulator Affairs Manager will assist with departmental policy and procedure development and implementation and will actively participate in Regulatory Affairs organizations such as RAPS while remaining Form CAQ-HR-002-F3 Job Description Template Rev. A. Page 2 of 3 current on potential changes in FDA policy, including submissions and compliance activities

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 Regulatory Affairs Manager U.S. Submissions role, contact a recruiter today at Andrew.Foran@argonmedical.com or apply online at www.argonmedicaljobs.co

Required Skills

Bachelor's Degree in science, math, or engineering discipline. An advanced degree is preferred
Certification: RAPS (RAC or RAC-US)
Ten years of work experience in U.S. Regulatory Submissions including experience as a regulatory team member on New Product Development Teams participating on at least ten (10) FDA 510(k) submissions required, with submission lead experience for at least three (3) submissions; OR, experience as a regulatory team member for three (3) FDA PMA submissions.
IDE support, review, and defense are required. Experience in pre-submission/Q-Sub meetings with FDA preferred
Prior experience interfacing with the FDA during inspections and technical presentations
IEC 60601 and eQMS experience preferred

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