Medical Device company looking for a Regulatory Specialist to join our growing, fast paced, energetic team. We design, manufacture and sell orthopedic implants for the foot and ankle.
The successful candidate will be responsible for:
Author submissions and other regulatory documents to obtain approval to bring new or modified products to market.
Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
Support marketing, new product development and operations in regulatory assessment of proposed changes. Perform and document regulatory assessments for modifications to existing devices.
Interface and coordinate with FDA and other regulatory agencies on submissions, approvals or other issues.
Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel.
Prepare and update US product listings and establishment registration.
Prepare and maintain international product registrations.
Monitor activities/publications of FDA and international regulatory bodies to identify and respond to new or revised regulatory requirements.
Represent Regulatory Affairs during FDA inspections or other government agency audits as required.
Bachelor’s Degree in a technical or scientific field
Minimum 3 years of experience in medical device regulatory affairs
Ability to interpret regulatory requirements and communicate them to technical functions within the company
510(k) submission experience
Internal Number: 0001
About Trilliant Surgical
Trilliant Surgical creates and manufactures innovative, reliable podiatric products that deliver better patient outcomes while fostering meaningful relationships for the advancement of podiatry. By providing brilliant, high-quality medical devices for small bone orthopedic correction and building strong relationships with surgeons who want to improve patient results and practice economics, we are Champions for Podiatry.