Regulatory Affairs Specialist

Epimed International - Dallas, TX (30+ days ago)3.3


Job Summary:

Epimed is a development, design, manufacturing, and distribution company creating innovative medical products for over 40 years. Our focus is to provide effective high quality specialty devices in the areas of pain management and regional anesthesia. We strive to continually provide and develop a variety of innovative, patented solutions for physicians with an emphasis on safety. Epimed has facilities located in Upstate New York and the Dallas/Fort Worth area. We have direct sales representatives across the US including Europe and distribute in over 40 countries.

We are currently seeking a Regulatory Affairs Specialist to assist and/or be the focal point for Epimed’s efforts to obtain new device approvals and the registration of new or support existing devices for our Dallas location. The Regulatory Affairs Specialist is responsible for maintaining a system by which to monitor the expiration of existing product certifications or licenses and perform the necessary work to renew these certifications or licenses.

Duties and Responsibilities:

  • Facilitate registration and licensing of products in foreign countries.
  • Act as a liaison between Epimed and the FDA, Notified Bodies, governmental agencies.
  • Obtain necessary 510k/ PMA/CE Certifications/Canadian Medical Licenses and renewals as necessary.
  • Acquire necessary training to be and act as Lead Auditor responsible for coordinating Epimed’s Internal Audit system.
  • Act as Epimed’s Recall Coordinator.
  • Other tasks and duties may be assigned as deemed necessary.

Requirements:

  • Bachelor’s Degree from a four year college or university; and at least three years related experience dealing with medical products and Quality Management System and/or training; or equivalent combination of education and experience.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from management, clients, vendors, and regulatory bodies.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions, to define problems, collect data, establish facts, and draw valid conclusions.
  • While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel; reach with arms; and talk or hear. The employee frequently is required to walk and sit. The employee is occasionally required to stand and stoop, kneel or crouch. Specific vision abilities required by this job include close vision, and ability to adjust focus due to computer work. Ability to sit at a computer terminal for an extended period of time

An Equal Opportunity Employer

Job Type: Full-time

Experience:

  • Regulatory: 3 years (Preferred)

Education:

  • Bachelor's (Required)