Regulatory Affairs Specialist

2 days ago


Oakland, California, United States The Fountain Group Full time
Regulatory Specialist II

The Fountain Group is seeking a highly skilled Regulatory Specialist II to join our team. This is a one-year contract position with the possibility of extension or conversion to permanent.

Job Summary

We are looking for a seasoned Regulatory Affairs professional with 5+ years of experience in medical device regulatory affairs. The ideal candidate will have a strong understanding of country-specific requirements and be able to communicate effectively with internal stakeholders.

Key Responsibilities
  • Responsible for regulatory activities, including product registrations, impact assessments, and compliance with international standards.
  • Understand country-specific requirements and deliver those to internal stakeholders for product registration and change planning.
  • Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss issues to solve.
  • Plan and execute tasks proactively in a timely manner.
  • Report status to a manager weekly.
  • Keep training records up to date to perform tasks efficiently.
Preferred Qualifications
  • Bilingual (Japanese or Chinese)
  • Knowledge of International Standards, such as ISO13485, IEC60601
  • Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH
  • Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency
  • Ability to manage time and projects
About The Fountain Group

The Fountain Group is a national staffing firm dedicated to providing top talent to our clients. We are committed to delivering exceptional service and building long-term relationships with our clients and candidates.



  • Oakland, California, United States The Fountain Group Full time

    The Fountain Group is seeking a Regulatory Specialist for a prominent client. This position is located in Alameda, CA and is a one year contract with the possibility of extension or conversion to permanent. The ideal candidate will have 5+ years of regulatory affairs experience, including medical device regulatory affairs. Responsibilities include regulatory...


  • Oakland, California, United States PG&E Corporation Full time

    {"Job Title: Regulatory Affairs ManagerJob Summary: We are seeking a highly skilled Regulatory Affairs Manager to join our team at PG&E Corporation. As a key member of our Regulatory Affairs organization, you will be responsible for managing regulatory proceedings for assigned cases, ensuring compliance with regulatory directives and stakeholder...


  • Oakland, California, United States The Fountain Group Full time

    Regulatory Specialist IIThe Fountain Group is a national staffing firm seeking a Regulatory Specialist for a prominent client. This position is located in Alameda, CA (onsite).Job Details:100% onsite positionHourly pay: $56.00 - $60.00 depending on experienceOne year contract with possibility of extension or conversion to...


  • Oakland, California, United States PG&E Corporation Full time

    Requisition ID: Not SpecifiedJob Category: Government and Regulatory RelationsJob Level: Director/ChiefBusiness Unit: Corporate AffairsWork Type: HybridJob Location: Not Specified Department OverviewIn the realm of Regulatory Affairs, our mission is to facilitate the achievement of corporate objectives by engaging with regulatory bodies and key stakeholders....


  • Oakland, California, United States Department Of Homeland Security Full time

    Job SummaryWe are seeking a highly skilled and experienced Public Affairs Specialist to join our team at the Department of Homeland Security. As a Supervisory Public Affairs Specialist, you will play a critical role in developing and implementing effective communication strategies to support our mission.Key ResponsibilitiesDevelop and execute comprehensive...


  • Oakland, California, United States Pacific Gas And Electric Company Full time

    Requisition ID: Not SpecifiedJob Category: Government and Regulatory RelationsJob Level: Individual ContributorBusiness Unit: Engineering, Planning & StrategyWork Type: HybridDepartment OverviewThe Core Gas Supply Department (CGS) is responsible for the procurement and management of natural gas supplies, including Renewable Natural Gas, as well as...


  • Oakland, California, United States PG&E Corporation Full time

    Job Title: Senior Case Manager - Regulatory AffairsLocation: Remote/HybridDepartment OverviewThe Regulatory Affairs division plays a pivotal role in facilitating our operational objectives by delivering specialized regulatory insights, overseeing compliance submissions, and representing our organizational interests with various stakeholders and regulatory...


  • Oakland, California, United States PG&E Corporation Full time

    Job Title: Senior Case Manager - Regulatory AffairsLocation: OaklandDepartment OverviewThe Regulatory Affairs division plays a vital role in enhancing our operational capabilities by delivering expert regulatory advice, managing compliance submissions, and representing our interests with various stakeholders and regulatory bodies. Our focus is on fostering...


  • Oakland, California, United States PG&E Corporation Full time

    Job Title: Senior Case Manager - Regulatory AffairsLocation: Remote/HybridDepartment OverviewThe Regulatory Affairs division plays a pivotal role in facilitating our operational success by delivering expert regulatory insights, managing compliance submissions, and representing our organizational interests with various stakeholders and regulatory bodies. Our...


  • Oakland, California, United States PG&E Corporation Full time

    Job Title: Senior Case Manager - Regulatory AffairsLocation: Remote/HybridDepartment OverviewThe Regulatory Affairs division plays a pivotal role in facilitating our operational success by delivering expert regulatory insights, managing compliance submissions, and representing our organizational interests with various stakeholders and regulatory bodies. Our...


  • Oakland, California, United States PG&E Corporation Full time

    Job Title: Senior Case Manager - Regulatory AffairsLocation: Remote/HybridDepartment OverviewThe Regulatory Affairs division plays a vital role in facilitating our operational success by delivering expert regulatory insights, managing compliance submissions, and representing our organizational interests with key stakeholders and regulatory bodies. Our focus...


  • Oakland, California, United States American President Lines Full time

    Job Title: Regulatory Compliance SpecialistCEVA Logistics is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our compliance team, you will be responsible for ensuring that our customs compliance areas meet all regulatory requirements.Key Responsibilities:Review and analyze customs compliance areas, import or...


  • Oakland, California, United States Department Of Homeland Security Full time

    Job SummaryThis is a challenging opportunity to serve as a Supervisory Public Affairs Specialist within the External Affairs team at the Department of Homeland Security. As a key member of the team, you will be responsible for leading a team of specialists in areas such as strategy and planning, media relations, creative and digital services, governmental...


  • Oakland, California, United States Block Communications Full time

    Job DescriptionBlock is seeking an experienced Regulatory Licensing and Exam Manager to join our growing legal team. This role is responsible for upholding Block's licensing and regulatory obligations in the lending space, ensuring compliance with applicable requirements while streamlining regulatory impact and facilitating innovation.Key...


  • Oakland, California, United States The Entrust Group Full time

    Job OverviewAbout UsWe appreciate your interest! For over four decades, The Entrust Group has been a leading provider of account administration services for self-directed IRAs. Our dedication to educating clients about self-directed retirement accounts and tax-advantaged plans, combined with our exceptional customer service, sets us apart in the industry....


  • Oakland, California, United States Pacific Gas and Electric Company Full time

    Position OverviewThe Senior Case Manager will oversee regulatory processes for designated cases, ensuring adherence to compliance standards and fostering stakeholder collaboration. This role may also involve creating case documentation, serving as an expert witness, implementing process enhancements, and participating in various special projects. This...


  • Oakland, California, United States Block Full time

    Company Overview Block is a unified organization comprised of various teams, all driven by a shared mission of economic empowerment. Our foundational teams — including People, Finance, Legal, Hardware, Information Security, and Platform Infrastructure Engineering — provide essential support and guidance at the corporate level. These teams collaborate...


  • Oakland, California, United States Blue Shield Of California Full time

    About the RoleWe are seeking a highly skilled Regulatory Filing Analyst to join our Government Programs Regulatory Law team. As a key member of our team, you will play a critical role in supporting the Medi-Cal and Medicare Advantage lines of business.Key ResponsibilitiesAssist with complex Department of Managed Health Care (DMHC) filings and provide...


  • Oakland, California, United States University of California , Riverside Full time

    {"title": "Admissions Recruitment Specialist", "content": "The Office of Student Affairs at the University of California, Riverside School of Medicine plays a vital role in enhancing the quality of student life experience throughout medical school. Student Affairs provides a range of services, including student enrollment, financial aid, academic records,...


  • Oakland, California, United States Block Full time

    Company Overview Block is a unified organization composed of various teams, all driven by the shared goal of economic empowerment. Our foundational teams — including People, Finance, Legal, Information Security, and Engineering — provide essential support and guidance at the corporate level. They collaborate across business sectors and global time...