REGULATORY AFFAIRS SPECIALIST
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