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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 whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
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.
QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
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. 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:
Regulatory Affairs Certification (RAC) can count towards 1 year of specific RA experience.
Master's degree can count towards 2 years of relevant (non-RA) experience.
Terminal degree (Doctorate or PhD in Business, Science, or related discipline) can count towards 4 years of relevant (non-RA) experience.
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 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, including experience supporting regulatory correspondence with Health Authorities and Notified Bodies related to postmarket actions (preferred).
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.
Trave is estimated 10 25% travel is required for this position. Ability to travel via car and/or airplane to domestic and international locations as needed.
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 training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your 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
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.
Unsolicited Agency Submission
Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidates name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.
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