Argon Medical Devices
Argon is a global manufacturer of specialty medical products. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Critical Care procedures. The Company’s products are sold globally through a combination of direct sales representatives and premier distributors.
Regulatory Affairs Manager
Full-time
Argon Medical Devices
Management
Argon
1445 Flat Creek Rd
75751 Athens , TX
Job Description: 

In this role, candidate will lead the Regulatory Affairs team and manage complex issues with multiple competing priorities having a direct impact on site operations and commercial opportunities. Develop strategies for worldwide governmental approval to introduce new products to market, provide advice on regulatory requirements, prepare worldwide submissions and facilitate their approval. Manage regulatory problems (e.g. adverse events) related to development, manufacturing, and commercialization and recommendation of action to senior leadership to ensure effective resolution. Facilitate CAPA system as well as lead Quality System internal audit programs.

This position will office in either our Athens, Texas or Plano, Texas locations, however successful candidate will be expected to spend significant time each week in the Athens, Texas facility where the Regulatory Affairs team is based.

Responsibilities Include: 
  • Coordinate, prepare and manage IDE, 510(k), and PMA submissions, supplements, certification, and annual reports.
  • Act as company representative, developing and maintaining positive relationship with FDA and notified body reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
  • Establish communications with International bodies to ensure smooth introduction of products within those markets including Japan and the European Union as well as all associated technical file construction and maintenance.
  • Coordinate the construction of Quality/Regulatory Agreements with all OEM customers to ensure regulatory relationships and responsibilities are clearly defined.
  • Review and approve scientific and promotional materials as well as documentation change requests to ensure regulatory compliance.
  • Support all internal and external engineering efforts in the development and design of new/modified products.
  • Orchestrate and implement the internal audit program.
  • Actively participate in Regulatory Affairs organizations to remain up to date on potential changes in FDA policy or surveillance activities.
  • Participate in RAB, FDA, or other third party audits and prepare evidence of Quality System compliance.
  • Maintenance and update documentation in accordance with company procedures, standards, and regulatory requirements.
  • Assist with departmental policy and procedure development and implementation.
  • The incumbent also assists with the training of less senior regulatory affairs personnel and provides work direction on projects of large scale.
  • Provide support to existing quality system ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Education/Experience: 
  • Bachelor’s Degree in science, math or engineering discipline required.  An advanced degree is preferred.
  • Certification is preferred: RAPS (RACUS, RACEU, and RACCAN) or ASQ (CMQ/OE, CQE, CQA-Biomed, etc).
  • Minimum 5 years pharmaceutical or medical device Class II or higher regulatory experience.
  • Significant experience with regulatory agencies interactions, PMA and 510(k), registration and compliance.
  • Solid understanding of and demonstrated proficiency in the use of domestic and international medical device standards; CFR’s, MDD, MHW Ordinances, etc.
  • Experience in performing internal audits.
  • Experience as Regulatory representative in a multi-functional project team environment.
Work Environment: 
  • Medical/Dental/Vision
  • FSA and Dependent Care
  • Company paid Life Insurance and AD&D
  • Supplemental Life
  • Company paid short-term and long-term disability
  • 401k Plan with employer contribution
  • Vacation/Personal/Holiday
  • Tuition Reimbursement Program