Compliance Manager leading Autodesk's Enterprise Compliance program. Ensuring compliance with SOX, PCI regulations and overseeing security controls across teams.
About the role
- Senior Regulatory Affairs Specialist at Medtronic ensuring regulatory compliance for medical technologies. Collaborating with teams to support submissions and maintain technical documentation.
Responsibilities
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
- Leads or compiles all materials required in submissions, license renewal and annual registrations
- Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities including design changes
- Write, update and maintain technical documentation
- Review promotional material for accuracy and compliance
- Keeps abreast of regulatory procedures and changes
- May direct interaction with regulatory agencies on defined matters
- Recommends strategies for earliest possible approvals of clinical trials applications.
Requirements
- Bachelor’s degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
- Experience in the medical device industry
- Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation)
- Excellent attention to details, proactive approach and ability to work independently
- High learning agility and ability to work under pressure
- Detail-oriented and organized, capable of managing multiple priorities while meeting strict regulatory deadlines.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Compliance Student supporting compliance and risk management activities for individual insurance at iA Financial Group. Involves monitoring processes, collaborating with teams, and assisting with compliance tasks.
Nurse Licensure & Compliance Coordinator managing multi - state nurse licensure and compliance inquiries while ensuring a positive nurse experience. Advocating for nurses and maintaining regulatory adherence at the organization.
508 Compliance Specialist working with the Office of the Inspector General for the DoD. Responsible for ensuring electronic accessibility for compliance with Section 508 regulations.
Senior Manager in Regulatory Affairs overseeing submission management and regulatory compliance. Leading cross - functional teams in a neuroscience - focused biopharmaceutical environment.
Local Compliance & Ethics Officer at Teva Germany serving local management and compliance program. Leading compliance initiatives and collaborating with various stakeholders while managing risks and providing guidance.
Manager of Asset Strategy and Regulatory Compliance driving asset management goals for Eversource. Ensuring regulatory compliance and system performance for electric transmission and substations.
IT Governance, Risk and Compliance Analyst managing compliance initiatives like NIST and ISO standards in technology and security operations.
Compliance Specialist overseeing regulatory adherence for youth programs in Gainesville. Ensuring DCF compliance and supporting youth program safety and integrity.
Technologist at FortisBC ensuring compliance with BCUC Critical Infrastructure Protection Standards. Focus on integrating business technology and providing technical support.