Regulatory Affairs Specialist
4 weeks ago
We are seeking a highly skilled Regulatory Affairs Analyst to join our team at San Francisco Health Plan. As a key member of our Regulatory Affairs and Compliance department, you will play a critical role in supporting essential regulatory affairs functions.
Key Responsibilities- Audit results, processes impacting healthcare providers, and NCQA accreditation standards.
- Support activities relating to regulatory inquiries, regulatory filings, reporting, and implementation of new regulatory guidance.
- Maintain inventory of policies and procedures in the organization's P&P database.
- Translate policy issues and regulatory requirements to clear and concise P&Ps.
- Ensure all P&Ps are reviewed frequently and updated as necessary.
- Work with other departments to develop new policies and coordinate P&Ps development and revisions across impacted departments.
- Communicate requirements and P&P changes to applicable SFHP management and staff.
- Train SFHP staff on development, revisions, and maintenance of Policies, Procedures, and Desktop Procedures.
- Oversee and conduct internal audits as assigned.
- Serve as department liaison with State agencies.
- Draft and oversee State regulatory filings.
- Analyze and coordinate implementation of new regulations and legislation.
- Bachelor's degree or equivalent combination of education and work experience.
- Two years of experience in analyzing and interpreting healthcare laws, regulations, and policies.
- Strong working knowledge of State program regulations and HIPAA.
- Healthcare Compliance Certification and data experience in healthcare desired.
- Health Benefits
- Medical: heavily subsidized by SFHP.
- Dental: choice of basic or enhanced dental plan.
- Vision: employee vision care coverage through VSP.
- Retirement: employer-matched CalPERS Pension and 401(a) plans, 457 Plan.
- Time off: 23 days of Paid Time Off (PTO) and 13 paid holidays.
- Professional development: opportunities for tuition reimbursement, professional license/membership.
Established in 1997, San Francisco Health Plan (SFHP) is an award-winning, managed care health plan whose mission is to provide affordable healthcare coverage to the underserved low and moderate-income residents in San Francisco County.
SFHP is chosen by eight out of every ten San Francisco Medi-Cal managed care enrollees, and its 175,000+ members have access to a full spectrum of medical services, including preventive care, specialty care, hospitalization, prescription drugs, and family planning services.
San Francisco Health Plan is proud to be an equal opportunity employer, committed to a work environment that supports, inspires, and respects all individuals and in which our people processes are applied without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, marital status, age, disability, national or ethnic origin, military service status, citizenship, or other protected characteristics.
Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
San Francisco Health Plan is an E-Verify participating employer.
Hiring priority will be given to candidates residing in the San Francisco Bay Area and California.
-
Regulatory Affairs Specialist
1 week ago
San Francisco, California, United States Yoh Full timeRegulatory Affairs Specialist Job DescriptionYoh is seeking a highly skilled Regulatory Affairs Specialist to join our team in St. Louis, Missouri. This individual will be responsible for planning and authoring pharmaceutical documents, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.Key Responsibilities:Plan...
-
Regulatory Affairs Specialist
3 weeks ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ACON Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Coordinate the preparation and...
-
Regulatory Affairs Specialist
4 weeks ago
San Francisco, California, United States Balchem Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at San Francisco Health Plan. As a key member of our Compliance and Regulatory Affairs Department, you will play a critical role in ensuring compliance with state and federal regulations, as well as developing and implementing policies to support our mission.Key...
-
Regulatory Affairs Specialist
3 days ago
San Mateo, California, United States Collabera Full timeJob Title: Regulatory Affairs SpecialistCollabera is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key Responsibilities:Perform data entry and maintenance of...
-
Regulatory Affairs Specialist
1 week ago
San Diego, California, United States Tandem Full timeJob Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Prepare and maintain domestic and international regulatory...
-
Regulatory Affairs Specialist
4 weeks ago
San Francisco, California, United States Balchem Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Compliance and Regulatory Affairs Department, you will play a critical role in ensuring our organization's compliance with state and federal regulations.Key ResponsibilitiesSubmit regulatory reports, including the annual Timely Access Report, to...
-
Regulatory Affairs Specialist
2 weeks ago
San Mateo, California, United States RICEFW Technologies Full timeJob Title: CMC Regulatory Affairs Data Entry SpecialistRICEFW Technologies is seeking a highly skilled and detail-oriented CMC Regulatory Affairs Data Entry Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for performing data entry using Gilead RIM System to support key CMC RA stakeholders.Key...
-
Senior Regulatory Affairs Specialist
4 weeks ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeJob SummaryRegulatory Affairs Specialist - CMCThis position manages multiple biological developmental projects with supervision, including working with contract manufacturing organizations CMO. The successful candidate will serve as the Regulatory Affairs (RA) CMC project representative to the CMC sub-team and the RA team, and will serve as an ad hoc member...
-
Regulatory Affairs Specialist II
3 days ago
San Francisco, California, United States Volt Full timeJob Title: Regulatory Affairs Specialist II - Medical DeviceVolt is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Develop and implement regulatory strategies for...
-
Regulatory Affairs Specialist
1 month ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs Specialist **About the Role** We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ACON Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements. **Key Responsibilities** *...
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...
-
Regulatory Affairs Specialist
3 days ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistAt ACON Laboratories, we are committed to developing innovative medical devices that enhance human life. We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.The ideal candidate will have a strong background in medical devices regulations and terminologies, with a minimum of 6-7 years of...
-
Regulatory Affairs Specialist
2 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...
-
Regulatory Affairs Specialist
3 days ago
South San Francisco, California, United States AbbVie Full timeJob Title: Regulatory Affairs ManagerAbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to ensure compliance with regulatory requirements.Key Responsibilities:Develop and implement regulatory strategies to ensure...
-
Regulatory Affairs Specialist
3 weeks ago
San Diego, California, United States Bayside Solutions Full timeJob Title: Regulatory Specialist, R&DBayside Solutions, Inc. is seeking a highly skilled Regulatory Specialist to join our R&D team. As a Regulatory Specialist, you will play a critical role in implementing worldwide regulatory programs for developing and marketed products and interacting with regulatory authorities to expedite approvals.Key...
-
Regulatory Affairs Specialist
3 days ago
South San Francisco, California, United States AbbVie Full timeJob Title: Regulatory Affairs ManagerAbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to our global development teams.Key Responsibilities:Develop and implement regulatory strategies for assigned products or...
-
Regulatory Affairs Specialist II
2 days ago
San Diego, California, United States Abbott Laboratories Full timeJoin Abbott Laboratories as a Regulatory Affairs Specialist IIAt Abbott Laboratories, we are committed to helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.We are...
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...
-
Regulatory Affairs Specialist
3 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...