Regulatory Transformation Specialist

Integra LifeSciences • Princeton, NJ

2d • $71,300 - $97,750

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Regulatory Transformation Specialist supports enterprise regulatory transformation initiatives by providing operational, analytical, and documentation support across Regulatory Intelligence, Policy and Advocacy, EU MDR compliance activities, process harmonization and remediation efforts. This role operates as an individual contributor and works under the direction of senior regulatory leaders to support the execution of global regulatory transformation initiatives. The Specialist assists in monitoring evolving regulatory requirements, maintaining regulatory intelligence tools and trackers, supporting process standardization efforts, and contributing to audit readiness and remediation activities. The role requires strong organizational skills, attention to detail, and the ability to work effectively across cross-functional teams within a regulated medical device or life sciences environment. Further, the Regulatory Transformation Specialist is expected to apply foundational regulatory knowledge, follow established procedures, and escalate issues appropriately while contributing to continuous improvement initiatives that enhance regulatory compliance, scalability, and operational effectiveness. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with minimal oversight.

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.
• Foundational knowledge of regulatory requirements applicable to medical devices and/or life sciences.
• 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.

Nice To Haves

• Certification in Regulatory Affairs Professional Society (RAC) encouraged.
• Familiarity with EU MDR, FDA regulations, ISO standards, and quality system concepts preferred.

Responsibilities

• Support enterprise regulatory transformation initiatives, including EU MDR compliance activities, US remediation efforts, and strategic regulatory programs.
• Monitor regulatory updates, standards, and guidance; maintain regulatory intelligence databases, trackers, and summary reports.
• Assist with competitor analyses, animal tissue monitoring activities, and documentation of regulatory impact assessments.
• 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.
• Support global labeling and label harmonization activities, including end-to-end labeling workflows and electronic Instructions for Use (eIFU) documentation.
• Track CAPA and nonconformance activities, maintain remediation documentation, and support inspection and audit readiness activities.
• Assist with regulatory documentation and compliance tracking for mergers, acquisitions, and integration activities.
• Support Compliance Master Plans, remediation initiatives, and continuous improvement projects within Regulatory Affairs.
• Support the development and maintenance of regulatory procedures and documentation that enable compliant device life cycle management across development, registration, and post‑market phases.
• 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.

Benefits

• 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 https://jobs.integralife.com/total-rewards/

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level