Regulatory Transformation Specialist - Field Action

Integra LifeSciences•Princeton, NJ

5d•Onsite

About The Position

The Regulatory Transformation Specialist – Field Actions supports enterprise‑wide Regulatory Transformation initiatives, with a primary focus on Field Actions. The role provides operational, analytical, and documentation support across transformation programs that impact postmarket regulatory activities, including but not limited to field action planning, execution, and compliance oversight. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal oversight. 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, while supporting additional transformation priorities as needed. Support the execution and tracking of global regulatory field action activities, including monitoring regulatory requirements, maintaining country‑specific timelines, and ensuring required documentation (e.g., notifications, effectiveness checks, closure records) is complete, accurate, and inspection‑ready. Support the execution and tracking of global regulatory field action activities, including monitoring regulatory requirements, maintaining country‑specific timelines, and ensuring required documentation (e.g., notifications, effectiveness checks, closure records) is complete, accurate, and inspection‑ready. Assist with preparation, maintenance, and coordination of field action documentation, including regulatory submissions, health authority communications, internal trackers, and supporting records, ensuring alignment with approved procedures and governance models. Support policy and advocacy activities, including preparation of policy summaries, tracking regulatory consultations and coordination of industry working group participation as they pertain to field actions. Assist in documenting, maintaining, and harmonizing regulatory processes, SOPs, templates, and process maps in support of field action compliance and other regulatory compliance 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 (e.g., premarket, post‑market, and change notifications) 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 to ensure business continuity, operational flexibility, and timely execution of regulatory priorities. This job description is not intended to be all‑inclusive; employees are expected to perform other duties as assigned that are relevant to departmental and business needs.

Requirements

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.
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.
Ability to travel via car and/or airplane to domestic and international locations as needed.

Nice To Haves

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.
Effective written and verbal communication skills, including experience supporting regulatory correspondence with Health Authorities and Notified Bodies related to postmarket actions (preferred).

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, while supporting additional transformation priorities as needed.
Support the execution and tracking of global regulatory field action activities, including monitoring regulatory requirements, maintaining country‑specific timelines, and ensuring required documentation (e.g., notifications, effectiveness checks, closure records) is complete, accurate, and inspection‑ready.
Assist with preparation, maintenance, and coordination of field action documentation, including regulatory submissions, health authority communications, internal trackers, and supporting records, ensuring alignment with approved procedures and governance models.
Support policy and advocacy activities, including preparation of policy summaries, tracking regulatory consultations and coordination of industry working group participation as they pertain to field actions.
Assist in documenting, maintaining, and harmonizing regulatory processes, SOPs, templates, and process maps in support of field action compliance and other regulatory compliance 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 (e.g., premarket, post‑market, and change notifications) 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 to ensure business continuity, operational flexibility, and timely execution of regulatory priorities.