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Regulatory Affairs Manager
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Manager, Public Affairs
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Abbott Alameda, United StatesAbbott is a global healthcare leader that helps 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 medic ...
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Manager, Public Affairs
1 week ago
Abbott Laboratories company Alameda, United StatesAbbott is a global healthcare leader that helps 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 medic ...
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Manager, Public Affairs
1 week ago
Abbott Laboratories Alameda, United StatesAbbott is a global healthcare leader that helps 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 medic ...
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Manager, Public Affairs
1 week ago
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Manager, Academic Affairs
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Sutter Health Emeryville, United StatesWe are so glad you are interested in joining Sutter Health · Organization: · SHSO-Sutter Health System Office-Bay · Position Overview: · Oversees Graduate Medical Education staff to achieve seamless management and execution of residency and fellowship programs. Provides overs ...
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Regulatory Affairs Manager
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Alameda Health System Oakland, United StatesRegulatory Affairs Manager · + Oakland, CA · + Quality · + Regulatory Affairs · + Full Time - Day · + Business Professional & IT · + Req #: · + FTE:1 · + Posted:February 16, 2024 · **Summary** · **SUMMARY:** Plans, coordinates, monitors compliance with federal, state an ...
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Regulatory Affairs Manager
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Mastech Digital Oakland, United StatesPosition: · HIM Director-Regulatory Affairs Manager · Location: · Oakland CA USA days onsite) · Duration: · 12+ Months (Possibility to extend/Convert) · Required Qualifications: · ● Bachelor's degree with additional 10 years of progressively responsible experience managing qu ...
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Manager, Academic Affairs
3 weeks ago
Sutter Health Emeryville, United StatesWe are so glad you are interested in joining Sutter Health · Organization: · SHSO-Sutter Health System Office-Bay · Position Overview: · Oversees Graduate Medical Education staff to achieve seamless management and execution of residency and fellowship programs. Provides oversigh ...
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Government Affairs Manager
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Western Resource West Valley City, United StatesPosition Summary: · Western Resource Advocates (WRA) is hiring a Government Affairs Manager to join our Utah team. The Government Affairs Manager will be responsible for leading WRAs legislative, regulatory, and administrative advocacy efforts in the state of Utah with direction ...
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government affairs manager
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Society for Nonprofits West Valley City, United StatesSalary Range: $73,000.00 To 90,000.00 Annually · Position Summary · Western Resource Advocates (WRA) is hiring a Government Affairs Manager to join our Utah team. The Government Affairs Manager will be responsible for leading WRAs legislative, regulatory, and administrative adv ...
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Manager, Community Affairs
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Levi Strauss & Co. San Francisco, United StatesJOB DESCRIPTION · You're an original. So are we · We're a company of people who like to forge our own path. We invented the blue jean in 1873, and we reinvented khaki pants in 1986. We pioneered labor and environmental guidelines in manufacturing. And we work to build sustainab ...
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Manager, Community Affairs
1 week ago
Levi Strauss & Co. San Francisco, United StatesJOB DESCRIPTION · You're an original. So are we. · We're a company of people who like to forge our own path. We invented the blue jean in 1873, and we reinvented khaki pants in 1986. We pioneered labor and environmental guidelines in manufacturing. And we work to build sustaina ...
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Regulatory Affairs Manager
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Hinge Health San Francisco, United States Regular Full timeHinge 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 fro ...
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Medical Affairs Manager
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ACL Digital San Mateo, United StatesTitle: Manager, Global Medical Affairs · Location: Foster, City, CA · Duration: Short term contract · Job Description · Manager, Global Medical Affairs (Hepatitis B) · This contractor role is within the LIFE (Liver, Inflammation, Fibrosis and Established Products) Medical Affa ...
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Medical Affairs Manager
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Net2Source Inc. San Mateo, United StatesHi, · My name is Gaurav and I am a recruiter with Net2Source Inc. Our direct client is looking to hire a Associate Manager - Medical Affairs* in their growing team. · Please find below the job description. · Position: Manager, Global Medical Affairs (Hepatitis B) · Location: Fost ...
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Medical Affairs Manager
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ACL Digital Foster City, United StatesTitle: Manager, Global Medical Affairs · Location: Foster, City, CA · Duration: Short term contract · Job Description · Manager, Global Medical Affairs (Hepatitis B) · This contractor role is within the LIFE (Liver, Inflammation, Fibrosis and Established Products) Medical Affa ...
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Medical Affairs Manager
3 days ago
Integrated Resources, Inc ( IRI ) Foster City, United StatesJob Title: Medical Affairs Manager · Location: Foster City, CA (Hybrid) · Duration: 6 Months (Possible extension) · Job Description: · Manager, Global Medical Affairs (Hepatitis B) · This contractor role is within the LIFE (Liver, Inflammation, Fibrosis and Established Products) ...
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Medical Affairs Manager
2 days ago
The Fountain Group Foster City, United StatesMedical Affairs Associate Manager located in Foster City, CA. Details for the position are as follows: · Pay Rate: $55.35/hr. · This is a hybrid role – onsite/remote · Job Description/Responsibilities: · Manager, Global Medical Affairs (Hepatitis B) · This contractor role is with ...
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Medical Affairs Manager
3 days ago
Infotree Global Solutions Foster City, United StatesOne of our leading Pharmaceutical client is looking for a Medical Affairs Manager (Hepatitis B). This is a global role that involves the development and execution of global strategies for products in the LIFE (Liver, Inflammation, Fibrosis and Established) category. This person w ...
Regulatory Affairs Manager - Oakland, United States - Mastech Digital
Description
Position: HIM Director-Regulatory Affairs Manager
Location: Oakland CA USA days onsite)
Duration: 12+ Months (Possibility to extend/Convert)
Required Qualifications:
● Bachelor's 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.
