Regulatory Affairs Specialist in Fort Worth, TX at Apex Life Sciences

Date Posted: 3/2/2018

Job Snapshot

Job Description

  • Works in close collaboration with internal stakeholders and supports multiple products.
  • Provides high quality global support for all marketed products through global expansion efforts and maintenance of approved products.
  • Partners with regions to assess and provide support documentation needs (e.g., certificates).
  • Ensures compliance with global regulatory requirements and adherence to internal policies and processes, and coordinates compliance activities at a global level
  • Provides support as needed for non-project related regional excellence activities.Implement and support Regulatory Impact Assessment Requests and global registrations required as a result of the Medical Device Regulation (MDR) implementation.
  • Bachelor's degree in a Scientific or closely related field
  • 3 years directly related regulatory experience
  • Demonstrates ability to coordinate and work effectively with cross functional teams.
  • Ensures timely, clear communication on project and regulatory approval status, issues, and risks with teams, GRA line management, key internal stakeholders, and with Health Authorities.
  • Serve as role model and embrace Corporate Values and Behaviors.
  • Committed to drive efficiency while maintaining quality
  • Demonstrates good organizational and time management skills, the ability to work on multiple projects, and adherence to timelines
  • Meets individual goals as defined in annual objectives

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.