Director of Governance and Compliance, Flywheel
Medical imaging AI development platform
Open for applications
Medical imaging AI development platform
101-200 employees
Open for applications
101-200 employees
Company mission
To play a part in accelerating discoveries that are changing the way healthcare is delivered to patients around the world.
Role
Who you are
- Minimum of 5-7 years of experience in regulatory compliance, preferably with healthcare or technology related industry
- Proven track record of developing, implementing, and overseeing governance frameworks and programs in a complex, multi-regulatory environment
- A strong understanding of IT security standards, privacy laws, and compliance regulations
- Detail Oriented, with a proven ability to spot inconsistencies or potential issues in a complex regulatory environment
- Strong analytical skills to assess compliance risks and develop effective mitigation strategies
- Proactive in identifying potential compliance issues and devising solutions before they escalate
- Deep knowledge of industry-specific regulations, standards, and best practices
- Proficient in using compliance management software and tools
- Familiarity with information security practices and how they intersect with compliance requirements
- Excellent project management and communication skills, including expertise in presenting complex regulatory frameworks to various audiences
- Advanced education or certification indicating a deeper understanding of compliance and regulatory affairs and a commitment to professional development
What the job involves
- Flywheel is seeking a Director of Governance and Compliance to join our dynamic Regulatory Affairs team
- This position will lead the strategic development and implementation of a comprehensive Compliance and Privacy framework tailored to corporate business objectives, regulatory frameworks, and compliance best practices
- This role is critical to ensure company operations and practices are compliant with state, federal, and international regulatory requirements and industry standards while effectively managing organizational risk
- The Director of Governance and Compliance will partner with the Director of Information Security to integrate compliance initiatives with the overall departmental and organizational strategies and collaborate cross-functionally to manage and mitigate compliance-related risks
- Maintain a clear understanding of business activities and all applicable and changing state, federal, and international laws and regulations
- Serve as the organizations SME to ensure regulatory practices are built into business unit initiatives for the entire development lifecycle
- Identify, plan, and prioritize organizational compliance and privacy activities based on risk and manage according to a prescribed cycle (e.g., through the development of the annual compliance plan)
- Manage compliance efforts across the organization, ensuring adherence to laws, regulations, and standards such as GDPR, 21 CFR Part 11, HITRUST, ISO 27001, HIPAA, and AI Frameworks
- Assist with preparing the Regulatory Affairs Departmental briefing for Executive Committee, Board of Directors, and Compliance Committees
- Develop and maintain the organizations GRC, policies and procedures, ensuring they align with business objectives and regulatory requirements
- Serve as a trusted advisor with business unit leadership and translate regulatory requirements into business unit initiatives and priorities
- Develop and implement the Flywheel Compliance, Risk, and Privacy Framework with plans to enable effective and resilient business services, architectures, and processes ensuring the company adheres to all relevant laws, standards, and regulatory requirements
- Collaborate with cross-departmental business unit stakeholders to integrate compliance and risk management into the security and compliance program organization-wide
- Lead the company-wide Enterprise Risk Management program, working closely and cross-functionally with other operational departments -- Product, Engineering, Business Operations, Sales, Support, Legal, and Human Resources -- to develop strategies to identify, evaluate, and mitigate risks and ensure on-going risk assessment and monitoring
- Oversee Internal and External Audit Assessments to evaluate compliance with internal policies, regulatory requirements, and contractual obligations
- Lead Third-Party Supplier Management Risk Assessments and program ensuring alignment with business objectives and organizational risk tolerances
- Manage supply chain management processes, including vendor assessments, due diligence, and ongoing monitoring
- Comply with company policies, including security, confidentiality, and data protection requirements, to maintain a secure work environment
Our take
Flywheel addresses the escalating complexity of data management in medical research by offering a platform tailored for advanced medical imaging research. Its solution integrates AI to streamline research and machine learning workflows, catering to the specific needs of researchers in this domain.
Offering a comprehensive suite of tools: the Flywheel Enterprise platform, Flywheel Data Exchange, and Flywheel Discovery, the company enables researchers to manage, exchange, and analyse medical imaging data efficiently. By providing curated datasets and a cohort discovery tool, Flywheel enhances researchers' ability to interpret large volumes of imaging data swiftly and intelligently, uncovering valuable insights that might otherwise go unnoticed.
Noteworthy successes include substantial funding, primarily directed towards supporting growth in public sector healthcare and pharmaceutical markets. Looking ahead off the back of a leadership refresh, Flywheel aims to expand its presence into Europe and potentially serve other stakeholders within the healthcare ecosystem, solidifying its position as a key player in medical research technology. Substantial shifts in the leadership team might well bring these visions to life.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
Company
Funding (last 2 of 8 rounds)
Jan 2025
$20m
LATE VC
Jun 2023
$54m
SERIES D
Total funding: $125.8m
Company HQ
Harrison, Minneapolis, MN
Leadership
Jim Olson
(Board Advisor)Chair Of The Board Of Directors at TruMotivate.com as well as Board Chair at Real Resources, where they used to be CEO. Former Co-founder, President and Board Director at the Livio Health Group.
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