Director Post Market Compliance

Hologic • Marlborough, MA • 1d ago

Marlborough, MA, United States

Newark, DE, United States

Hologic is a global leader in medical devices and diagnostics dedicated to improving lives through innovative healthcare solutions. The Director of Post Market Compliance, Corporate plays a critical role in ensuring that the company's systems for managing product and customer concerns are effective, compliant, and continuously improving. This role leads corporate oversight of complaint handling, post market surveillance, medical device reporting, vigilance, and field actions while collaborating with global teams to maintain regulatory compliance and enhance product quality.

Knowledge

Deep understanding of medical device regulatory requirements and compliance standards across domestic and international markets.

Knowledge of complaint handling, post market surveillance, medical device reporting, vigilance, and field action processes.

Familiarity with FDA-regulated cGMP environments and audit requirements.

Understanding of quality management systems and electronic complaint/quality record systems.

Awareness of emerging regulatory changes and their impact on post market processes.

Skills

Strong leadership and stakeholder management skills with the ability to influence cross-functional and international teams.

Strategic and analytical thinking to translate corporate goals into actionable plans.

Project and program management capabilities to drive process improvements.

Data analysis skills using quality data management tools to identify trends and improvement opportunities.

Effective communication and reporting skills for presenting performance metrics and quality insights to senior leadership.

Behavior

Demonstrating strong accountability for regulatory compliance and product quality.

Collaborative and proactive in working with multiple departments including service, IS, and international teams.

Results-driven mindset focused on continuous improvement and operational efficiency.

Strong problem-solving approach when identifying compliance gaps and implementing corrective actions.

Commitment to fostering a culture of quality and transparency across the organization.

Experience

Bachelor's Degree in business, engineering, science, or a related discipline, or equivalent experience.

Minimum of 10 years of progressive experience in quality assurance within the medical device industry.

Proven experience managing post market processes such as complaints, vigilance, and field actions.

Demonstrated success in managing audits in FDA-regulated cGMP facilities.

Experience leading teams, managing projects, and building a strong culture of quality.

Why join Hologic?

We are committed to making Hologic the destination for top talent. 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 $170,700 - $303,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, 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.

LI-NK1

Hologic

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