Highly Competitive Salary
  1. Permanent
  2. RA Intelligence
  3. United States
Santa Ana, California
Posting date: 17 Jul 2019

Proclinical is currently seeking a Regulatory Affairs Specialist for its client located in Santa Ana, CA. Successful candidate will coordinate, compile, and supply regulatory documents to regulatory teams in Latin America, Asia Pacific and Europe, Middle East and Africa for new product registrations, new product introductions, renewals, and change submissions, etc.

Job Responsibilities:

  • Working with regulatory partners to ensure rapid and timely approval of new products and renewals.
  • Researching, collecting data, and addressing requests from regulatory agencies to prepare documentation required for health authority submissions
  • Monitoring the external environment to help ensure compliance with new regulations, requirements, etc.
  • Working under minimal supervision, with benefit of previous regulatory experience.
  • Requiring a general use and application of Regulatory concepts, practices and techniques.
  • Developing solutions to a variety of problems of moderate scope and complexity.
  • Performing other duties as assigned by the manager of this position.

Skills and Requirements:

  • BA/BS and 2+ years' regulatory affairs work experience is required.
  • Knowledge of European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is preferred.
  • Experience with Quality Management System Standard ISO 13485 is preferred.
  • Knowledge of International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) is preferred.
  • Excellent written and oral communication skills are required.
  • Good analytical thinking, organization, problem solving, and investigative skills are required.
  • Proficiency in Microsoft Office and all related applications is required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Maya Smith at (+1) 267-405-6995 or upload your resume on our website -

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.