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Sr. Regulatory Compliance Specialist

Marlborough, MA, United States

Are you a seasoned regulatory professional ready to make a global impact in the medical device industry? Hologic is seeking a **Senior Regulatory Compliance Specialist** to lead the charge in ensuring our corporate policies and procedures meet the highest standards of compliance with laws, regulations, and industry benchmarks.

If you’re passionate about regulatory affairs, thrive in a collaborative environment, and want to contribute to advancing healthcare worldwide, we’d love to hear from you!

Knowledge

+ Deep understanding of global medical device regulatory frameworks and Quality Systems Management requirements.

+ Expertise in domestic and international medical device regulations, including standards and guidance documents.

+ Familiarity with regulatory submissions and compliance processes.

Skills

+ Strong analytical and critical thinking skills to assess regulatory changes and their impact on policies and procedures.

+ Excellent verbal and written communication skills for cross-functional collaboration and stakeholder engagement.

+ Proven ability to manage and prioritize multiple projects in a fast-paced environment.

+ Proficiency in MS Office software programs for documentation and reporting.

+ Ability to design and deliver training materials effectively.

Behaviors

+ Proactive and solution-oriented approach to regulatory challenges.

+ Collaborative team player who thrives in cross-functional environments.

+ Highly organized with strong time-management skills to meet deadlines.

+ Detail-oriented with a commitment to accuracy and compliance.

+ Adaptable to changing regulatory landscapes and business needs.

Experience

+ A minimum of 5 years of experience in Medical Device Regulatory Affairs, with a proven track record in domestic and international submissions.

+ Demonstrated success in conducting regulatory assessments and implementing compliance programs.

+ Experience in managing corrective and preventive actions (CAPAs), non-conformances (NCs), and Quality Plans.

+ History of contributing to cross-business unit projects and overcoming obstacles through collaboration.

The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position.

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 $83,000-$129,700 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.

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