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Alameda Health System
Daly City, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemAlameda Health System
Oakland, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemAlameda Health System
Concord, CA, United States
Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, O
Job Source: Alameda Health SystemNevro
Redwood City, CA, United States
Regulatory Affairs Manager Company: Nevro Location: Redwood City, CA Position Type: Full Time Experience: See below Education: See below Regulatory Affairs Manager at Nevro in Redwood City, CA Req. Masters deg in RA, Biomedical Engg or Med. Device Engg, & 6 years exp as RA Manager or RA Specialist or rel. occupation in RA, or Bachs deg in RA, Biom
Job Source: NevroAlameda Health Sytem
Oakland, CA, United States
SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, OSHPD, CD
Job Source: Alameda Health SytemHinge Health
San Francisco, CA, United States
Overview: About the Role In this role as a Regulatory Affairs Specialist, you will have responsibility for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain and expand regulatory approval of Hinge Healths medical device portfolio. This Specialist will work with internal and 3rd party ex
Job Source: Hinge HealthHinge Health
San Francisco, CA, United States
Hinge Health is moving people beyond pain by transforming the way it is treated and prevented. Connecting people digitally and in-person with expert clinical care, we combine advanced technology, AI and a care team of experts to guide people through personalized care directly from their phone. Our approach is proven to reduce pain by 68%, prevent 4
Job Source: Hinge HealthHinge Health
San Francisco, CA, United States
Hinge Health is moving people beyond pain by transforming the way it is treated and prevented. Connecting people digitally and in-person with expert clinical care, we combine advanced technology, AI and a care team of experts to guide people through personalized care directly from their phone. Our approach is proven to reduce pain by 68%, prevent 4
Job Source: Hinge HealthOakland, CA, United States
Position: HIM Director-Regulatory Affairs Manager
Location: Oakland CA USA 94612 (5 days onsite)
Duration: 12+ Months (Possibility to extend/Convert)
Required Qualifications:
● Bachelors degree with additional 10 years of progressively responsible experience managing quality compliance/assurance functions. Masters’ degree may substitute for two years of experience
● Comprehensive knowledge of FDA, ICH, EMEA regulations and guidelines
● Minimum five years in a quality management role with direct reports
● In-depth knowledge of 21 Code of Federal Regulation Parts 11, 312 and 820, and experience with Quality Management Systems
● Demonstrated experience identifying areas for improvement and implementing solutions;
●ensuring compliance with standards, regulations and company procedures; and administering successful programs within appropriate timelines
● Experience conducting training for quality assurance and/or regulatory affairs
● Ability to interact positively with all levels of staff and external contacts
● Proficiency in Microsoft Word, Outlook, Excel and PowerPoint
● Excellent verbal and written communication skills
● Experience adopting a flexible, proactive, and service-oriented approach
● Travel may be required
Desired Knowledge, Skills and Abilities:
● Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society for Quality) Certification is preferred
● Experience with on-site monitoring
● Expert planning and organization skills
● Strong attention to detail
● Exceptionally team focused; actively contributes to a positive and innovative work environment
● Able to demonstrate the highest ethical standards; promotes trust, respect and integrity
● Spanish language skills a plus
Additional Job details
• Oversee all aspects of Regulatory staffing, operations, systems, and expansion.
• Set vision and strategy for expanding regulatory teams that include both staff recruitment and retention strategies, and portfolio expansion strategies.
• Establish and operationalize policies, Standard Operating Procedures (SOPs), and quality assurance processes that ensure program compliance; partner with CRS Compliance and Regulatory Affairs Program to align with existing policies and systems.
• Partner with Clinical Research Management (CRM) to establish and maintain well-defined work flows, roles and responsibilities, and communications to ensure effective integration between regulatory and clinical operations.
• Oversee management and system support for an enterprise-wide eRegulatory and eSubject management system, Florence, including on-boarding, training, SOP management, user group engagement, trial migration, and quality control.
• Create roadmap and oversee implementation of new Florence modules, functionality, and integrations with other Consortium systems.
• Identify Regulatory improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to Consortium study teams.
• Lead change management across study teams in support of increased regulatory management; establish faculty relationships and channels of communications to keep faculty apprised of central regulatory operations.
• Form strong partnerships with disease group teams and Clinical Trials Program leaders, developing standard report-outs for each centrally managed portfolio.
Email Alert for Regulatory Affairs Manager jobs in Oakland, CA, United States
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