Compliance Manager

Compliance Manager
**This is a remote, work-from-home position. 

Who we are:

83bar is redefining patient recruitment, engagement, and journey management. We deliver the right patient, at the right time, to the right place for clinical trials and commercially approved medical devices and diagnostics. We push patient recruitment further, faster, and provide insights, analysis, and oversight using our patient activation capabilities. The result? Qualified, informed, and high-intent patients for your clinical trial, drug, diagnostic, or device.

Job Description:

The Compliance Lead works on the Research & Development team to support 83bar to ensure that the organization’s operations and procedures meet government and industry compliance standards. This position will primarily be focused on quality management, security, and privacy, ensuring regulatory alignment across corporate and client-facing teams.. This position reports directly to the Chief Finance Officer with a dotted line to the VP of Contracts and Information Technology. 

Duties/Responsibilities: 

• Works closely with the compliance committee (technology, client services, call center, and legal) to report on KPIs, lead, and support compliance program initiatives. 
• Lead the development, maintenance, and continuous improvement of the Quality Management System (QMS). 
• Perform periodic reviews of documents, lead management reviews, facilitate the opening and closure of CAPAs, tracking, and reporting on training status..
• Plan and execute internal audits; support external and client audits and remediation activities.
• Review draft contracts to ensure all compliance commitments are relevant and actionable.
• Manage vendor and supplier qualification processes and related documentation.
• Participate in and lead client-facing meetings related to compliance.
• Conduct compliance risk assessments and Data Privacy Impact Assessments (DPIAs). 
• Ensure compliance with global privacy regulations and internal security policies.
• Research proposed and newly effective regulations, including HIPAA, GDPR, GxP, HITRUST, SOC 2, ISO 13485/9001/27001, and FDA QMSR,  by reviewing regulatory bulletins and other sources of information, accountable for reviewing regulatory and industry requirements and assessing our compliance, and keep leadership and staff abreast of applicable requirements and our compliance plans.. 
• Projects create a positive image of the organization for employees, customers, the industry, and the community. Performs other related duties as assigned. 

Required Skills/Abilities: 

• Experience with Quality Management System frameworks (e.g., ISO9001, ISO13485, FDA QMSR)
• Knowledge of Information Security Frameworks ( e.g., ISO 27001, SOC 2).
• Deep knowledge of HIPAA, GDPR, GxP, ISO standards, and other applicable regulatory frameworks..
• 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. 
• Ability to manage cross-functional initiatives in a remote-first, fast-paced environment.

Preferred Skills/Abilities: 

• Certification in Quality (e.g., ISO 9001 Lead Auditor), Privacy (e.g., CIPP/US or CIPP/E), or Security (e.g., ISO 27001).
• Working knowledge of 21 CFR Part 11 and FDA 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. 

Education: 

• Bachelor’s Degree in Business or related field or equivalent experience. 
• Extensive and diversified background with at least 6 years in compliance, quality, or data protection in life sciences, health tech, or pharma..

Physical Requirements & Work Environment: 

• Prolonged periods of sitting at a desk and working on a computer.
• This is a remote role with flexible working hours. 
• Occasional travel may be required for audits, client meetings, or team collaboration sessions.