Regulatory Inspection Specialist

This position supports the California Department of Public Health’s (CDPH) mission and strategic plan by promoting health and wellness and improving state health outcomes by advancing protective measures and reducing risks.

The Senior Environmental Scientist (ES) (Specialist) is a Drug and Medical Device Compliance and Enforcement Section (DMDCES) regulatory inspection technical expert. The incumbent serves in a lead capacity, reviewing and evaluating drug, medical device, home medical device retailer (HMDR), and cosmetic inspection reports generated by field staff for completeness, uniformity, thoroughness, and accuracy. The Regulatory Inspection Specialist assesses the timeliness of the inspections and ensures firms operate in compliance with applicable drug and medical device safety laws and regulations. The incumbent collaborates with other DMDCES staff and provides input as needed to revise inspection reports or conduct follow-up activities with firms. The incumbent also reviews and makes recommendations regarding licensed entities complaints; develops and delivers classroom and field training to inspectors pertaining to inspection processes; and manages the program’s continuous improvement projects.

The selected candidate works under the general direction of the Chief, Food and Drug Unit of the DMDCES, Investigations and Technical Support Unit and serves as a back-up with the medical device contract between the CDPH Food and Drug Branch (FDB) and the U.S. Food and Drug Administration (FDA). Additionally, they will be responsible for planning, organizing, monitoring, evaluating and conducting the most complex medical device safety inspections under the FDA Medical Device Safety Contract; prepares and reviews contract inspection reports; and may participate in other aspects of contract management.

 THERE IS ONE VACANCY BEING ADVERTISED ACROSS MULTIPLE COUNTIES. THE INCUMBENT WILL BE HEADQUARTERED IN THE COUNTY NEAREST THE RESIDENCE OF THE SELECTED CANDIDATE. THE COUNTIES ARE: Sacramento, Contra Costa, Fresno, Los Angeles, San Bernardino, San Diego, and Orange county 

• Serve in a lead capacity by reviewing and evaluating drug, medical device, cosmetic, and HMDR inspection reports for completeness, accuracy, uniformity, and thoroughness.

• Assess the appropriateness of corrective actions taken by regulated firms and enforcement actions performed by FDB personnel.

• Coordinate with FDB supervisors to revise inspection reports, clarify findings, or conduct necessary follow?up activities.

• Conduct appropriate follow?up at unlicensed firms to determine compliance status and initiate enforcement when needed.

• Conduct or lead the most complex inspections of drug, medical device, and HMDR facilities.

• Provide scientific, technical, and regulatory guidance to inspectors regarding violations, inspection procedures, and documentation.

• Review complaints involving licensed entities and make recommendations for investigative or enforcement activity.

• Develop and deliver classroom and field training to inspectors related to inspection processes, regulatory requirements, and documentation standards.

• Assist supervisors with workplan development, including inventory review, assignment planning, and workload management.

• Lead and support continuous improvement projects to enhance workflow efficiency, adopt new technologies, update process flows, or revise application forms.

• Maintain and update the section’s documented training program, adding new components such as audit processes, new training modules, and ongoing staff retraining.

• Serve as a backup inspector under the FDA Medical Device Safety Contract, including planning, organizing, conducting, and monitoring the most complex contract inspections.

• Prepare detailed medical device contract inspection reports in accordance with FDA requirements.

• Draft responses to media and legislative inquiries regarding the inspection program.

• Analyze proposed legislation and assist with regulatory development efforts related to the drug and medical device inspection program.

• Represent FDB on workgroups, task forces, conferences, and meetings involving inspection program issues and regulatory policy.

• Attend required trainings and maintain up?to?date knowledge of new technologies, emerging trends, and evolving state and federal regulatory requirements related to drug and medical device safety.

• Strong knowledge of state and federal laws and regulations governing drugs, medical devices, cosmetics, and HMDR entities, with the ability to interpret and apply complex regulatory frameworks.

• Demonstrated analytical and problem?solving skills, including the ability to review inspection findings, identify systemic issues, evaluate corrective actions, and recommend appropriate enforcement or follow?up.

• Excellent written and verbal communication skills, including the ability to prepare clear inspection reports, policy responses, and training materials; effectively communicate with supervisors, colleagues, regulated industry, media, and legislative stakeholders.

• Experience conducting inspections, investigations, audits, or regulatory compliance work, preferably in drug, medical device, or other highly regulated environments.

• Leadership experience or the ability to serve in a lead capacity—providing guidance, technical direction, and training to inspection staff.

• Experience developing and delivering training (classroom or field?based), particularly in inspection processes, documentation standards, or regulatory compliance.

• Strong attention to detail and accuracy in evaluating reports, documenting violations, and reviewing corrective actions.

• Ability to collaborate effectively with diverse teams, management, federal partners (including FDA), and other stakeholders.

• Strong organizational and time?management skills, including the ability to prioritize assignments, meet deadlines, and support workplan development.

• Adaptability and willingness to learn new technologies, update processes, and lead continuous improvement initiatives.

• Experience analyzing legislation or contributing to regulation development is highly desirable.

• Ability and willingness to represent the program in workgroups, task forces, conferences, and external meetings.