REGULATORY AFFAIRS SPECIALIST

Employer
PRESCIENT IMAGING, INC.
Location
Hawthorne, California
Salary
-
Posted
April 09 2018
Position Type
Full Time
Job Type
Other

Hawthorne, LA County based company seeks a full time REGULATORY AFFAIRS SPECIALIST.  The position will report to REGULATORY AFFAIRS MANAGER, and the position requires the performance of the following:

  • Coordinate, prepare, and review regulatory submissions for FDA requirement such as 510k, IDE, and device listing
  • Coordinate, prepare, and review regulatory submissions for European Medicines Agency, such as notify body, ISO and CE Mark
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes
  • Compile and maintain regulatory documentation databases or systems (FDA Quality System Regulations, ISO 13485)
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues
  • Prepare or maintain technical files as necessary to obtain and sustain product approval
  • Participate in internal or external audits (ISO Certification Audit)
  • Develop or conduct employee regulatory training
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
  • Write or update standard operating procedures, work instructions, or policies.

Successful candidate must have a Bachelor’s degree in Management of Drug Development, and 12 months of work experience as a Quality Assurance Specialist.

Successful candidate must also have 12 months of experience with the following:

  • PLM system
  • Project management system such as MS Project
  • FDA inspection experience per 21 CFR Part 820
  • Audit experience per ISO 13485:2016

Travel is not required.

Submit resume to

Employer: PRESCIENT IMAGING, INC.

Job Site: 12569 CRENSHAW BLVD, HAWTHORNE, CA 90250

Contact: FARHAD DAGHIGHIAN - PRESIDENT

QR@PRESCIENTIMAGING.COM