envelopeinfo@pac-dent.com phone1-909-839-0888    

Job Title: Regulatory Affairs Specialist


Pac-Dent Inc. is looking for a Regulatory Affairs Specialist to work at 670 Endeavor Circle, Brea, CA 92821


Job Duties:

  • Coordinate, prepare, and review regulatory submissions. 
  • Review product promotional materials, labeling, batch records, specification sheets, and test methods for compliance with applicable laws, regulations and policies.
  • Maintain current knowledge base of existing and emerging laws, regulations, standards, and guidance documents. 
  • Interpret regulatory rules and rule changes and ensure that they arecommunicated through corporate policies and procedures.
  • Coordinate efforts associated with the preparation of regulatorydocuments or submissions.
  • Obtain and distribute updated information regarding domestic and international laws, regulations, guidelines, or standards.
  • Recommend changes to company procedures in response to changes in laws, regulations, and standards.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification and follow-up of submissions under review.
  • Determine the types of regulatory submissions and internal documentation that are required.

Qualifications:

Master's degree in Laws or Regulatory Affairs.


Contacts:

Qualified applicants please forward resume to Pac-Dent Inc., 670 Endeavor Circle, Brea, CA 92821. Attn: HR. No phone calls please.