We are representing an international medical device company in their search for a Compliance & Contracts Manager in Greater Chicago, IL.
Why Join Us:
• The leader in their field, our mission-driven client provides a life-saving solution to patients every day
• You will report directly to the Vice President Regulatory, Clinical and Quality Affairs, with responsibility for enterprise-wide compliance, ethics and privacy
• Private, technology-driven business with an existing culture of compliance and ethical practices
Responsibilities:
• Reporting to the Vice President Regulatory, Clinical and Quality Affairs, you will take ownership of the development, implementation, and ongoing management of the organization’s practices to mitigate compliance and privacy risks
• You will interact with all levels of the organization and function as an integral team member in advancing compliance with GDPR, Sunshine Act, HIPAA, OSHA, data retention and other compliance and privacy-related laws and policies in line with industry best practices
• This position will also maintain the companywide contracts management system and will be a member of the company’s Information Security Team
• Work with leadership and outside counsel to develop, implement and enforce policies to ensure company is complying with regulations.
• Take ownership of implementing phase II and III GDPR program that will include conducting audits and
assessments to determine priorities to ensure GDPR compliance
• Identify and evaluate the company’s current data processing activities and maintain records
• Work with Sales/Marketing and Finance to periodically evaluate compliance with Sunshine Act reporting
requirements to maintain transparency and accurate recordkeeping
• Partner with IT and HR on reviewing policies for Code of Conduct, Acceptable Use (of company
equipment), Internet, etc.
• Work with QA to maintain and disseminate communications and policies pertaining to OSHA standards
for Exposure Control Plan and Hazard Communication (hazcom), employee health & safety, blood borne
pathogens, fire safety, etc.
• Make recommendations to improve organizational practices including companywide training and
awareness communications
• Develop risk management strategies and inform department leaders
• Work cross-functionally to educate department leaders about regulations that apply to their work
• Partner with legal, HR and other stakeholders to conduct and resolve potential compliance investigations
• Work with other members of the Information Security Team to investigate potential security breaches
• Maintain the company’s contracts management database by adding new agreements, setting automated notifications for milestone reports, payments, and expirations, and alerting internal stakeholders
• Work with legal to maintain current forms of agreements for confidentiality, clinical trials, product
distribution, material transfers, etc. and ensure current versions are being implemented
• Collect and manage Certificates of Insurance related to contracts to ensure adequate levels of coverage
are maintained and that insurance clause requirements are adhered to
Requirements:
• Education: Bachelor’s degree required; Advanced degree (JD , Masters, etc.) preferred
• Compliance Experience: You must bring exposure to international compliance and privacy work, including GDPR and Sunshine Act regulations
Application Process for Compliance & Contracts Manager:
Qualified professionals are to submit resume to Steve Harrison: steve@conselium.com
