Hologic, Inc. · 2 months ago
Manager, Field Actions
Newark, DE, United States
Full-time
Onsite
Mid, Senior Level
$107K/yr - $178K/yr
8+ years expHologic, Inc. is dedicated to enhancing global healthcare compliance and patient safety. They are seeking an experienced Field Actions Manager to lead the coordination and execution of global field actions, ensuring compliance with regulatory requirements and maintaining high standards of quality and safety.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead the coordination and execution of global field actions, ensuring compliance with regulatory requirements and maintaining high standards of quality and safety
Collaborate cross-functionally with divisional and corporate teams to develop health risk assessments, recall strategies, regulatory communications, and remedial action plans
Manage and coordinate cross-functional teams to execute global field actions effectively
Schedule meetings, develop deliverables, and assign ownership for field action activities
Coordinate regulatory communications across regional and international teams
Collaborate with Design Assurance and Quality teams on health risk assessments and remedial action plans
Qualification
Required
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
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
Benefits
Comprehensive training when you join as well as continued development and training throughout your career
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-17
2026-01-17
Company data provided by crunchbase