Pac-Dent Inc. headquartered in Brea, CA, is a fast-growing international design, manufacturing and wholesale dental product and device company. Founded in 1992, Pac-Dent has earned the reputation as one of the best and most reliable in the dental industry. Pac-Dent serves its customers through state-of-the-art manufacturing, strong research and development capabilities, innovative approach to lean operations, and superior customer service by constantly adapting to market and customer needs. With its mission of Passion for Excellence, Pac-Dent focuses on delivering the highest quality, technologically advanced and innovative products in the preventive, restorative, teeth whitening, endodontic and infection control segments.
The Regulatory Assistant is the member of the Regulatory Affairs (RA) team to ensure continued regulatory compliance for all products. This position will work with cross-functional teams and 3rd party test labs to ensure completion of product testing required for global approvals and license.
The Regulatory assistant will conduct literature review, gather documents required for global product approvals/license including U.S. 510(k)’s, EU MDR, China FDA license, and other approvals as required. The Regulatory Assistant reports to Regulatory Affairs Director/Manager directly.
Assis with management to ensure product/process compliance with the requirements of ISO 13485, FDA QSR, EU MDR, MDSAP, etc.
Assist in the review and implementation of internal regulatory procedures to ensure regulatory compliance to maintained or enhanced.
Assist in securing the required product approvals including document submissions to regulatory authorities and notified bodies.
Assist with Design, Research and Development project team to ensure compliance with Design Control Requirements.
Maintain existing approvals including submission of renewal paperwork.
Maintain regulatory files based on regulatory and post-market requirements.
Assist with training in the business unit and facilities to ensure personnel are familiar with and knowledgeable regarding regulatory and associated reporting requirements.
Other duties or projects may be assigned.
Required Education and Experience:
Bachelor’s degree in science or engineering from an accredited 4-year university.
This is an entry level position, no previous experience is needed
Preferred Education and Experience:
Bilingual in English and Chinese.
This position has no direct supervisory responsibilities, but does serve as a coach and mentor for other positions in the department.
Only local candidates will be considered