We are currently looking for a compliance professional who will be responsible for the design and implementation of standards, tools and templates to support the Hologic’s Compliance Program in the United States.

• Develop and implement compliance policies and procedures to ensure adherence to applicable laws, regulations, and industry standards.
• Collaborate with relevant stakeholders across Hologic divisions to ensure U.S. Hologic Compliance policies, SOPs, and training programs are consistent with federal and local requirements.
• Perform and support day-to-day compliance operational activities, including monitoring, auditing, and reporting activities to ensure compliance with internal policies and external regulations; oversee day-to-day compliance operational activities.
• Collaborate with cross-functional teams, including Regulatory Affairs, Internal Audit, Marketing, Sales and other relevant departments, to ensure compliance requirements are met throughout the organization.
• Oversee and manage the training program. Support regular compliance training and education programs for employees to promote awareness and understanding of compliance policies and procedures.
• Stay up-to-date with changes in regulations and industry best practices, and proactively communicate relevant updates to key stakeholders.
• Support execution of investigations into compliance-related incidents, including conducting interviews, gathering evidence, and recommending appropriate corrective actions.
• Manage relationships with internal and external auditors to facilitate compliance audits and ensure timely resolution of any identified issues.
• Support the preparation of board-related compliance materials.
• Drive compliance analytics strategy and deployment of analytics subject matter expertise.

• Bachelor’s degree in a relevant field such as business, law, or healthcare administration. Advanced degree preferred.
• Minimum of 5-7 years of experience in medical device/pharmaceutical compliance, with a strong understanding of applicable laws, regulations, and industry guidelines.
• Proven experience in managing compliance operations, including monitoring, auditing, and reporting activities.
• Excellent knowledge of U.S. medical device/pharmaceutical industry standards, including AdvaMed Code of Ethics.
• Exceptional communication and interpersonal skills, with the ability to collaborate and build relationships with stakeholders at all levels.
• Detail-oriented with strong analytical and problem-solving abilities.
• Ability to work in a fast-paced and dynamic environment, managing multiple priorities and deadlines.
• Proficient in using compliance management software and tools.
• Professional certifications in compliance, such as Certified Compliance and Ethics Professional (CCEP), are highly desirable.