Manager, Compliance Operations

Marlborough, MA, United States

Manager, Compliance Operations

Legal Shared Services

At Hologic, our mission is to help our patients everywhere lead longer, healthier lives. We support this mission by offering cutting-edge technologies in the areas of breast cancer diagnosis and treatment, cervical cancer screening and molecular diagnostics, and gynecological surgical procedures, to name a few.

The ethos of Hologic is embedded in all that we do and across all functions. The Legal Department at Hologic supports the company’s mission by providing high quality, timely and pragmatic legal support to its clients. We are a partner to the business, serving the critical role to ensure that we always act with integrity; protect our patients, customers and employees; safeguard our corporate assets and engage in our business activities in compliance with all applicable laws.

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. The Manager, Compliance Operations will have lead oversight and coordination of critical aspects of an effective compliance program and will be responsible for ensuring adherence to regulatory requirements and industry standards and overseeing and managing compliance operations within the organization. This role requires a strong understanding of medical device compliance, strong leadership abilities, and the ability to effectively collaborate with cross-functional teams. This position will be based in Marlborough, Massachusetts with potential hybrid in-office/remote flexibility.

If you are an innovative, collaborative, solution-oriented, business-minded partner and thrive in a dynamic organization, you will be an integral member of this team. Being forward thinking, adaptable and responsive is key as the Hologic legal team does not function on the periphery. Rather, we are full members of our business teams and contributing towards our shared business goals, always driving the business forward. In return, you will be embraced and supported by a team of smart, creative, hard-working and passionate business colleagues dedicated to a purpose much higher than themselves.

Responsibilities of this role include the following:

• 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.

Education and Experience:

• 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.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $117,000 to $195,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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