Full Job Description
The Regulatory Specialist - Field Actions supports enterprise wide Regulatory Transformation and Operations 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 health hazard evaluation (HHE) coordination, field action planning, execution, and compliance oversight. 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. The Specialist assists with tracking and supporting field action requirements across markets, maintaining and organizing required documentation, and contributing to process harmonization and standardization efforts that enable scalability and inspection readiness. In addition to field action support, the role contributes to broader Regulatory Transformation efforts by applying foundational regulatory knowledge to evolving processes, systems, and governance models. The Specialist is expected to follow established procedures, proactively escalate risks or issues, and support continuous improvement initiatives that strengthen regulatory compliance, data integrity, and operational effectiveness across the organization.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal oversight.
3 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.
3 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.
3 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.
3 Assist with preparation, maintenance, and coordination of field action documentation, including HHE coordination, regulatory submissions, health authority communications, internal trackers, and supporting records, ensuring alignment with approved procedures and governance models.
3 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.
3 Assist in documenting, maintaining, and harmonizing regulatory processes, SOPs, templates, and process maps in support of field action compliance and other regulatory compliance activities.
3 Track CAPA and nonconformance activities, maintain remediation documentation, and support inspection and audit readiness activities.
3 Support Compliance Master Plans, remediation initiatives, and continuous improvement projects within Regulatory Affairs.
3 Maintain awareness of regulatory pathways applicable to medical devices (e.g., premarket, post-market, and change notifications) and escalate issues or risks as appropriate.
3 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.
3 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.
DESIRED MINIMUM QUALIFICATIONS
3 Bachelors, Masters or Doctorate/PhD degree in Science, Engineering, Regulatory Affairs, or other technically related field.
3 Minimum of 2-4 years related experience with increasing responsibility in an FDA regulated industry such as Medical Devices, Biotech or Pharma. Certification in Regulatory Affairs Professional Society (RAC) encouraged. One (1) year of experience in a RA role is expected out of the 2-4 years minimum requirement. Education or certification in lieu of relevant experience accepted when the requirements below are met:
3 Regulatory Affairs Certification (RAC) can count towards 1 year of specific RA experience.
3 Masters degree can count towards 2 years of relevant (non-RA) experience.
3 Terminal degree (Doctorate or PhD in Business, Science, or related discipline) can count towards 4 years of relevant (non-RA) experience.
3 Foundational knowledge of regulatory requirements applicable to medical devices and/or life sciences.
3 Working knowledge of Field Actions, Corrections and Removals, Recalls, FSNs/FSCA, and market-specific notification requirements.
3 Ability to support field action execution activities, including preparation and maintenance of recall dossiers, notifications, effectiveness checks, and closure documentation.
3 Familiarity with EU MDR, FDA (21 CFR Parts 806, 820, 821) regulations, ISO standards, and quality system concepts preferred.
3 Strong organizational skills with the ability to manage multiple tasks, trackers, and documentation deliverables simultaneously.
3 High attention to detail and accuracy in documentation and data maintenance.
3 Ability to follow established procedures, templates, and governance models.
3 Effective written and verbal communication skills, including experience supporting regulatory correspondence with Health Authorities and Notified Bodies related to postmarket actions (preferred).
3 Ability to work collaboratively with cross-functional stakeholders.
3 Proficiency with common business systems and tools (e.g., document management systems, spreadsheets, databases).
3 Demonstrated ability to learn new regulatory concepts, tools, and processes.
Salary Pay Range:
$71,300.00 - $97,750.00 USD Salary
Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or trainingIn addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensationYour recruiter can share more about the specific salary range for your preferred location during the hiring process.
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences
