• Manager, Field Actions

    Hologic (Marlborough, MA)


    Manager, Field Actions

     

    Newark, DE, United States

     

    Marlborough, MA, United States

     

    Are you ready to make a meaningful impact on global healthcare compliance and patient safety? At Hologic, we are seeking an experienced **Field Actions Manager** to lead the coordination and execution of global field actions, ensuring compliance with regulatory requirements and maintaining the highest standards of quality and safety. In this critical role, you’ll collaborate cross-functionally with divisional and corporate teams to develop health risk assessments, recall strategies, regulatory communications, and remedial action plans. If you thrive in a fast-paced, regulated environment and are passionate about driving excellence in field safety corrective actions, this is your opportunity to join a team that empowers people to live healthier lives every day.

    Knowledge:

    + Expertise in regulatory requirements, including 21 CFR Part 7 Subpart C (Recalls), 21 CFR Part 806 (Reports of Corrections and Removals), FDA Quality System Regulations, ISO 13485:2016, and EU Medical Device Regulation regarding field safety corrective actions.

    + Familiarity with FDA Industry Guidance for Recalls and guidance on distinguishing recalls from medical device enhancements.

    + Understanding of MEDDEV 2.12/1 guidelines for market surveillance and medical device vigilance systems.

    + Comprehensive knowledge of health risk assessments, remedial action assessments, and recall strategy development.

    Skills:

    + Proven ability to manage and coordinate cross-functional teams to execute global field actions effectively.

    + Strong organizational and project management skills to schedule meetings, develop deliverables, and assign ownership for field action activities.

    + Excellent communication skills to coordinate regulatory communications across regional and international teams.

    + Proficiency in Agile systems for processing field action records and documentation.

    + Analytical skills to collaborate with Design Assurance and Quality teams on health risk assessments and remedial action plans.

    + Ability to navigate complex regulatory environments and maintain compliance with evolving standards and guidelines.

    Behaviors:

    + Proactive and detail-oriented, ensuring thorough and timely execution of field actions and regulatory communications.

    + Collaborative and team-oriented, fostering productive relationships with divisional stakeholders and global QA/RA representatives.

    + Strategic thinker, balancing regulatory compliance with operational efficiency to achieve organizational goals.

    + Results-driven, demonstrating accountability for deliverables and a commitment to continuous improvement.

    + Adaptable and resilient, managing competing priorities in a fast-paced, regulated industry.

    Experience:

    + Bachelor’s degree in a related field required.

    + **8+ years** of experience in the medical device industry, with a strong focus on regulatory compliance and field safety corrective actions.

    + Hands-on experience coordinating global recall strategies, regulatory communications, and health risk assessments.

    + Proven track record in implementing FDA and international regulatory requirements for recalls and market surveillance.

     

    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 $106,700-$177,800 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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