Overview: ISIS Services seeks experienced Manager of Regulatory Affairs & Quality Assurance to be responsible for overall development, application and improvement of GLP Quality System. The Manager of Regulatory Affairs & Quality Assurance will apply understanding of medical device regulations to ensure the organization is in compliance. Additionally, this position will work toward continual process improvement by leading quality system implementation and providing related training. Specific Duties and Responsibilities: IACUC Assure completion of semiannual facility inspection and program evaluation. Assure coordination of routine/monthly meetings and complete minutes of meetings. Conduct protocol review process and maintain all IACUC documentation (amendments, deviations, approval letters, annual progress reports, inspection and evaluation findings, appointment letters member votes, etc.). Assure training is provided to staff, committee members, and investigators on an as-needed basis. Distribute approved protocols to Project Manager and/or OR staff for conduct of study. Distribute amendments and all other pertinent protocol information to update study documentation. Track animal usage. AAALAC Participate and support AAALAC accreditation efforts Assist in Program Description development and updating the Description as required by AAALAC. Submit and file annual reports. Maintain all correspondence with agency. Participate in site visit. Assure that ISIS follows the recommendations of the Guide. NIH/ PHS Comply with assurance requirements: filing annual reports, maintaining correspondence with agency, updating Assurance as required by NIH/PHS. USDA Participate in site inspections Assure all license requirements are met: filing annual reports to APHIS, compliance to AWA regulations and USDA Policies. Quality Assurance (QA) Maintain GLP Master Schedule Conduct Semiannual Internal QA audits and GLP vendor facility audits based on CFR 58. Complete semiannual water quality monitoring. Responsible for oversight of scheduling calibration & maintenance, maintain records of equipment. Provide QA oversight of all GLP projects Generate GLP Reports Participate in FDA site visits DEA Comply with regulations by maintaining licensing requirements and all correspondence with agency regarding controlled substances. Assure that the ISIS Controlled Substance Program is implemented and maintained. Update license as needed. Participate in site visit. DHS Radiation/ California Radiologic Health Branch Comply with regulations by maintaining licensing requirements and all correspondence with agency regarding radioactive materials and/or equipment. Update license as needed. Participate in site visit. Other Responsibilities: Occupational Health and Safety: Serve as member of EH&S committee Complete minutes of meeting MSDS - maintain internal files Responsible for fire extinguisher program Standard Operating Procedures (SOP)/ Study Documentation: Responsible for document control and archiving of ISIS SOPs, forms, and study data. Process SOP revisions, implement new SOPs, update all SOP binders Train as needed Local Agencies: Maintain all regulatory requirements and correspondence for local agencies (City and County), i.e., Hazardous Materials Business Plan and others. Other duties as assigned. Edication/Experience/Skills Required: Course work in biological sciences and/or bachelors degree in related field Experience with and participation in FDA, USDA, AAALAC, and other regulatory agency audit. Ability to implement, maintain, audit and enhance the Quality Program Demonstrated ability to respond effectively to needs of clients, colleagues, and inspectors Ability to train on regulatory topics as well as standard hands-on techniques. Excellent oral and written communication skills. Basic understanding of medical biology and familiarity with the demands of medical device industry. Proficient in Microsoft Word, Excel and PowerPoint, e-mail and Internet. Special Factors: Must be able to work with various departments to assure effective implementation of RA/QA program. Equally important is the ability to work independently, exercise good judgment, and use diplomacy and tact in dealing with internal and external customers. Background or coursework in quality assurance a plus. Bachelors degree in biological science or animal science preferred. Certification with AALAS, or RAPS beneficial.