Job description
About the Opportunity
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.
Environment
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.
We’re highly responsive to customer needs and constantly strive to make a positive contribution to the biomedical and life sciences communities we serve. Team members are recognized and rewarded when advocating for customer success and satisfaction over other concerns. We value self-motivated, creative individuals who work well in a collaborative environment – constantly generating and sharing innovative ideas and solutions with the team.
Flywheel has a comprehensive benefits package and encourages a balanced work life and home life.
Responsibilities
- 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.
What would make you a great fit
- 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.
Do you feel like you don’t have everything that’s listed above? If you have some of the skills and experience that we’re looking for and are willing to use your talent to learn the rest, we encourage you to apply!
About Us
Flywheel is the leading research data platform that’s transforming the way biomedical and imaging data are managed at leading life sciences, clinical, and academic institutions globally.
Flywheel provides a comprehensive research data solution with all the tools needed for curation, imaging processing, machine learning workflows, and secure collaboration. By leveraging cloud scalability and automating research workflows, Flywheel helps organizations scale research data and analysis, improve scientific collaboration, and accelerate discoveries.
Company Values
GO STEADY WITH LEVITY
The alchemy of effective teamwork happens when we each take ownership of both the menial and the magical every day. We’re serious, but never stuffy. We keep our cool under pressure because we assume best intentions and maintain perspective. This allows for true teamwork, with a dash of irreverence.
WORK BETTER TOGETHER
We are tenacious and united in our pursuit of solving our customers’ biggest challenges, and no challenge is too big. Diverse backgrounds across our team make us more effective as we listen, absorb, collaborate, and iterate to innovate.
FIGURE IT OUT
We’re obsessed with uncovering the why of any given. Having an open mind allows us to be quick to fail and quick to adapt. We relentlessly pursue continual improvement through learning and imagining new possibilities.
GIVE A SHIT
We’re fueled by grit, boundless energy, and a deep belief that we are doing cool shit. We don’t hesitate to stand up and speak out because we trust that through tough, honest discourse we can drive change and make a real difference for our customers and our mission.
