Changing lives. Building careers.

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 operations specialist position provides support across multiple functional areas, including regulatory intelligence, device establishment registration and listing (FURLS), global unique device identification (UDI), publishing, and translations. The role also involves proficient use of the Regulatory Information Management System (RIMS) to ensure data accuracy and process efficiency. A strong understanding of global regulatory requirements, both U.S. and international, is essential, along with familiarity with regulatory affairs processes. Responsibilities include performing data analysis, managing data uploads and verification, and ensuring high-quality, timely support for the Global Regulatory Affairs function and broader organizational compliance at Integra LifeSciences.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential job duties and responsibilities include, but are not limited to:

• Monitors regulatory intelligence activities by tracking new regulations, standards, policies, and guidance issued by relevant authorities.  Analyzes and summarizes requirements, conducts gap assessments, gathers impact data, and prepares comprehensive reports to inform regulatory strategy and compliance.

• Understand and execute the requirements of Unique Device Identification (UDI) regulations for on-going global compliance (e.g., FDA GUDID, EUDAMED, AUSUID etc.).

• Develop and maintain a strong understanding of Regulatory Information Management (RIM) system functionality and applicable regulatory requirements.  Leverage this knowledge to support regulatory processes, ensure data integrity within the system and associated systems, and contribute to the accuracy and efficiency of regulatory operations.

• Act as the liaison and provide guidance for the Integra translation program.  Ensure governance tracking logs are maintained, and copies of supporting documentation are maintained. 

• Supports resolution of blocked order issues by conducting necessary research and assessments to facilitate the timely release of products from distribution holds.

• Coordinates, collaborates with Integra facilities, and executes the Device Establishment Registration and Listing program (FURLS) to ensure compliance with regulatory requirements.

• Supports Regulatory Management in the preparation and coordination of regulatory submissions. Ensures submission components are accurate, complete, and compiled in accordance with applicable guidelines and timelines.  Assists in managing submission logistics, including formatting, tracking, and filing to Regulatory Authorities, while maintaining proper documentation and version control.

• Contributes to creating an environment that promotes collaboration, trust, regulatory excellence, creativity, and initiative.

• Develop and maintain standard operating procedures, and work instructions related to Global UDI, Device Establishment Registration and Listing, and Translations as well as other Regulatory Operations activities including training on those processes.

• Keeps apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may affect the company.

• Performs other relevant duties as assigned.

Qualifications:

• Bachelor’s degree in science or business-related field with 3-5 years of experience working in a regulated industry

• Prior experience with process documentation and automation

• Familiarity with regulatory submission formats, including eStar, eCTD, and paper submissions.

• Proficiency with publishing software and document management systems (e.g., Veeva Vault, Master Control, ISI Toolbox, etc.).

• Must possess and demonstrate an understanding of FDA Regulations, ISO 13485 Standard, European Medical Device Regulation, Canadian Medical Device Regulations, Japanese QMS Ordinance, Australian Therapeutic Goods (Medical Devices) Regulations, Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) and other International Regulations as required

• Demonstrates excellent writing, project management and communication skills

• Advanced proficiency in MS Office Suite (Excel, PowerPoint, Word) and Adobe Pro for tracking, reporting, formatting and presenting information

• Capable of multi-tasking and problem solving

• Familiarity with reading and interpreting regulatory data or similar technical information and extraction of data

• Excellent attention to detail and organizational skills

• Utmost discretion with confidential information

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.

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