Regulatory Transformation Specialist - Field Action

Regulatory Transformation Specialist – Field Actions

Supports enterprise‑wide Regulatory Transformation initiatives with a primary focus on Field Actions. Provides operational, analytical, and documentation support across transformation programs impacting postmarket regulatory activities, including field action planning, execution, and compliance oversight.

• Support enterprise regulatory transformation team initiatives with a primary focus on Field Actions (recalls, corrections and removals, FSN/FSCA activities, and other postmarket regulatory obligations).
• Execute and track global regulatory field action activities, monitoring regulatory requirements, maintaining country‑specific timelines, and ensuring required documentation (notifications, effectiveness checks, closure records) is complete, accurate, and inspection‑ready.
• Prepare, maintain and coordinate field action documentation, including regulatory submissions, health authority communications, internal trackers, and supporting records.
• Support policy and advocacy activities: prepare policy summaries, track regulatory consultations, and coordinate industry working group participation as they pertain to field actions.
• Document, maintain and harmonize regulatory processes, SOPs, templates, and process maps in support of field action compliance and other regulatory activities.
• 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 escalating issues or risks as appropriate.
• Participate in cross‑training and support activities to ensure business continuity, operational flexibility, and timely execution of regulatory priorities.

• Bachelor’s, Master’s or Doctorate/PhD degree in Science, Engineering, Regulatory Affairs, or a related technical field.
• Minimum of 2‑4 years of related experience with increasing responsibility in an FDA‑regulated industry (Medical Devices, Biotech, or Pharma).
• Certification in Regulatory Affairs Professional Society (RAC) encouraged; one year of RA experience is expected.
• 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.
• Familiarity with EU MDR, FDA (21 CFR Parts 806, 820, 821) regulations, ISO standards, and quality system concepts preferred.
• Strong organizational skills, high attention to detail, ability to manage multiple tasks and documentation deliverables simultaneously.
• Effective written and verbal communication skills, with experience supporting regulatory correspondence with Health Authorities and Notified Bodies.
• Ability to work collaboratively with cross‑functional stakeholders.
• Proficiency with common business systems and tools (document management systems, spreadsheets, databases).
• Demonstrated ability to learn new regulatory concepts, tools, and processes.
• Estimated 10–25% travel required.

$71,300.00 – $97,750.00 USD

Integra Life Sciences is an equal opportunity employer, committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, color, religion, sex, age, national origin, sexual orientation, disability, or protected veteran status. All applications will receive full consideration.