Regulatory Specialist – Field Actions

This position operates as an individual contributor under the direction of senior regulatory leaders and supports the execution of global regulatory field action activities within a broader regulatory transformation framework.

Responsibilities

• Support enterprise regulatory transformation team initiatives with a primary focus on Field Actions, including recalls, corrections and removals, FSN/FSCA activities, and other postmarket regulatory obligations.
• Support the execution and tracking of global regulatory field action activities, including monitoring regulatory requirements, maintaining country-specific timelines, and ensuring required documentation is complete, accurate, and inspection-ready.
• Assist with preparation, maintenance, and coordination of field action documentation, including HHE coordination, regulatory submissions, health authority communications, internal trackers, and supporting records.
• Support policy and advocacy activities, including preparation of policy summaries, tracking regulatory consultations and coordination of industry working group participation.
• Assist in documenting, maintaining, and harmonizing regulatory processes, SOPs, templates, and process maps in support of field action compliance.
• Track CAPA and nonconformance activities, maintain remediation documentation, and support inspection and audit readiness activities.
• Support Compliance Master Plans, remediation initiatives, and continuous improvement projects within Regulatory Affairs.
• Maintain awareness of regulatory pathways applicable to medical devices and escalate issues or risks as appropriate.
• Serve as an active member of the broader Regulatory Transformation and Operations group; participate in cross-training and support activities as assigned.

Minimum Qualifications

• Bachelors, Masters or Doctorate/PhD degree in Science, Engineering, Regulatory Affairs, or other technically related field.
• Minimum of 2-4 years related experience with increasing responsibility in an FDA regulated industry such as Medical Devices, Biotech or Pharma.
• One (1) year of experience in a RA role is expected out of the 2-4 years minimum requirement.
• Foundational knowledge of regulatory requirements applicable to medical devices and/or life sciences.
• Working knowledge of Field Actions, Corrections and Removals, Recalls, FSNs/FSCA, and market-specific notification requirements.
• Ability to support field action execution activities, including preparation and maintenance of recall dossiers, notifications, effectiveness checks, and closure documentation.
• Strong organizational skills with the ability to manage multiple tasks, trackers, and documentation deliverables simultaneously.
• High attention to detail and accuracy in documentation and data maintenance.
• Ability to follow established procedures, templates, and governance models.
• Effective written and verbal communication skills.
• Ability to work collaboratively with cross-functional stakeholders.
• Proficiency with common business systems and tools (e.g., document management systems, spreadsheets, databases).
• Demonstrated ability to learn new regulatory concepts, tools, and processes.

Preferred Qualifications

• Certification in Regulatory Affairs Professional Society (RAC) encouraged.
• Familiarity with EU MDR, FDA (21 CFR Parts 806, 820, 821) regulations, ISO standards, and quality system concepts preferred.
• Experience supporting regulatory correspondence with Health Authorities and Notified Bodies related to postmarket actions preferred.