Manager Regulatory Affair at Capgemini Engineering coordinating activities for the US market. Preparing submissions to the FDA and collaborating with internal teams for regulatory compliance.
About the role
- Senior Manager of Compliance and Privacy responsible for compliance program and policies at Aeroflow Health. Leading efforts in regulatory compliance and enhancement of privacy practices.
Responsibilities
- Support and continuously enhance Aeroflow’s compliance and privacy program
- Drive a strong, values-based culture of compliance across the organization
- Support the development and implementation of compliance and privacy policies, procedures, and standards
- Monitor regulatory changes and assess impact on existing policies and operations
- Design and deliver compliance and privacy training programs for employees, leaders, and key stakeholders
- Track training completion and effectiveness, and recommend improvements as needed
- Oversee and conduct investigations into alleged or identified compliance and privacy issues
- Manage internal reporting mechanisms and ensure issues are escalated appropriately
- Develop and oversee corrective action plans to address identified compliance and privacy gaps
- Monitor remediation efforts to ensure issues are resolved and controls are strengthened
- Work closely with the Associate General Counsel and Legal team on regulatory matters, enforcement actions, and risk management
- Partner with Operations, IT, Security, and other teams on privacy, data protection, and compliance initiatives
Requirements
- Bachelor’s degree from an accredited university or college
- Advanced degree preferred
- Minimum 8 years of leadership experience in healthcare compliance, privacy or management
- Thorough knowledge of healthcare, HIPAA and state privacy regulations
- Experience in a management role and the ability to direct and develop others
- Certifications in privacy and/or compliance
Benefits
- Competitive Pay
- Health Plans with FSA or HSA options
- Dental and Vision Insurance
- Optional Life Insurance
- 401K with Company Match
- 12 weeks of parental leave for birthing parent/ 4 weeks leave for non-birthing parent(s)
- Additional Parental benefits to include fertility stipends, free diapers, breast pump
- Paid Holidays
- PTO Accrual from day one
- Employee Assistance Programs
- SO MUCH MORE!!
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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