Responsible for the inspection of all assigned medical device manufacturing and home medical device retail facilities to ensure compliance with the Sherman Food, Drug and Cosmetic Law (Division 104, Part 5, California Health and Safety Code), the Code of Regulations, program policy and nationally recognized standards. Incumbents plan, perform and may implement the more responsible, difficult and complex as well as the routine, general and specialized investigations or studies of medical device manufacturing and Home Medical Device Retailer facility operations and practices.Performs preliminary and secondary analysis, research, surveys, and investigations of typical medical device manufacturing and Home Medical Device Retailer practices. Prepares staff reports that document the violation of laws and regulations; provides recommendations for corrective actions and/or sanctions; reviews corrective action plans; resolves issues between the regulated community and the Department; ensures monitoring for completion of proposed corrective actions. Participates in enforcement actions that are coordinated or directly by the Department’s Office of Legal Services, the State Attorney General, and local district attorneys. May participate in administrative office hearings.Provides technical assistance and consultation to the medical manufacturing and Home Medical Device Retailer facility industries to ensure program understanding and compliance with the law, regulations and other program requirements. Coordinates requests from local enforcement agencies to ensure operational compliance with statutory, regulatory, and departmental requirements. Coordinates and provides training on the proper management of medical device manufacturing and Home Medical Device Retailer Facility and facility self-assessment.Prepares routine and complex correspondence, special reports, and other assignments as needed. May prepare issue memorandums, controlled correspondence and legislative reports. Represents the Medical Device Safety Program at regional local enforcement agency meetings, public meetings and conferences.
Education: Possession of a bachelor's or advanced degree with a major in a biological, chemical, physical, or environmental science, or a closely related scientific discipline. (Admission to a masters or doctoral degree program in a biological, chemical, physical, or environmental science, or a closely related scientific discipline shall be considered to meet these education qualifications.) All interested applicants must submit a standard State Application Form STD 678, and must clearly indicate the basis of their eligibility in the 'Explanation' box of the STD 678. Applications without eligibility information will not be considered. Applications will be screened and only the most qualified candidates will be interviewed.
580 - 618 - 0762 - 001
Final Filing Date:
Medical Device Safety Unit 1500 Capitol Ave MS 7602 95814
If you are not a current or former State employee, you must first take an examination to obtain list eligibility. This does not apply to Student Assistant vacancies.
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The State of California is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.