Pac-Dent Inc. is looking for a Regulatory Affairs Specialist to work at 670 Endeavor Circle, Brea, CA 92821
- 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.
Master's degree in Laws or Regulatory Affairs.
Qualified applicants please forward resume to Pac-Dent Inc., 670 Endeavor Circle, Brea, CA 92821. Attn: HR. No phone calls please.