Regulatory Affairs Specialist
2 days ago
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 SummaryWe 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.
- 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
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.
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Regulatory Affairs Specialist
2 weeks ago
Oakland, California, United States The Fountain Group Full timeThe 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...
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Regulatory Affairs Manager
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Regulatory Affairs Specialist
6 days ago
Oakland, California, United States The Fountain Group Full timeRegulatory 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...
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Chief Advocate for Regulatory Affairs
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Public Affairs Specialist
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Senior Regulatory Case Manager
4 weeks ago
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Senior Regulatory Case Manager
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Oakland, California, United States PG&E Corporation Full timeJob 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...
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Senior Regulatory Case Manager
4 weeks ago
Oakland, California, United States PG&E Corporation Full timeJob 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...
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Senior Regulatory Case Manager
4 weeks ago
Oakland, California, United States PG&E Corporation Full timeJob 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...
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Senior Regulatory Case Manager
4 weeks ago
Oakland, California, United States PG&E Corporation Full timeJob 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...
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Senior Public Affairs Manager
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Lead Regulatory Case Manager
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