Manager, Field Actions

Hologic•Newark, DE

42d

About The Position

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.

Requirements

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.
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.
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.
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.