83bar · 4 hours ago
Compliance Lead
United States
Full-time
Remote
Senior Level
5+ years exp
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Hiring Manager
Lauren Rhodes
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Responsibilities
Maintains Quality Management System (QMS), and reports on the health of the QMS to the compliance committee. This includes – performing periodic reviews of documents, leading management reviews, facilitating the opening and closure of CAPAs, tracking and reporting on training status, supporting clients, and internal audits, completing client questionnaires, and participating in client meetings.
Works closely with the compliance committee (technology, client services, call center, and legal) to lead and support compliance program initiatives.
Review draft contracts to ensure all compliance commitments are relevant and actionable.
Research proposed and newly effective regulations by reviewing regulatory bulletins and other sources of information accountable for reviewing regulatory and industry requirements and assessing our compliance.
Oversee internal compliance risk investigations, in conjunction with upper management and the compliance committee.
Research proposed and newly effective regulations for applicability to 83bar, and keep leadership and staff abreast of applicable requirements and our compliance plans. compliance.
Projects create a positive image of the organization for employees, customers, the industry, and the community. Performs other related duties as assigned.
Qualification
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Required
Knowledge of Quality Management System frameworks (e.g., ISO9001, ISO13485, FDA QMSR)
Knowledge of Information Security Frameworks (e.g., ISO 27001, SOC 2)
Understanding of US privacy laws and their practical implementation (e.g., HIPAA)
Knowledge of Quality Management Systems and/or Information Security Management software
Knowledge of Good Clinical Practices regulations
Superior verbal and written communication and interpersonal skills
Excellent organizational skills and attention to detail
Excellent analytical, decision-making, and problem-solving skills
Ability to review and create Standard Operating Procedures
Bachelor’s Degree in Business or related field or equivalent experience
Extensive and diversified background with at least 5 years of related experience
Preferred
Has a healthcare quality and/or regulatory background (medical devices, pharmaceuticals, biologics, clinical research)
Knowledge of 21 CFR Part 11 regulations
Understanding of international privacy laws and their practical implementation (e.g., GDPR)
Quality Management and/or Information Security related certifications
Extremely proficient in Google Workspace Suite, Microsoft Office Suite, or related software
Experience with healthcare, marketing, technology services, or call centers
Company
83bar
83Bar is a leader in connecting patients to providers that care and innovations that make a difference.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
HCAP PartnersBigfoot Capital
2021-01-21Debt Financing
2019-04-30Debt Financing
Leadership Team
Robert Baurys
founder and CEO
Company data provided by crunchbase
