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Regulatory Specialist

1 month ago

Princeton, United States Integra LifeSciences Full time

Integra LifeSciences - Regulatory Specialist - Princeton, New Jersey

Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is responsible for implementing regulatory strategies for the Company with a focus on achieving compliance with all current and upcoming regulations in the US and EU. Responsibilities include: Providing regulatory input for regulatory documentation and development or sustaining projects to ensure that regulatory requirements are met. Analysis and review of data, resolution of regulatory issues of moderate scope. Creation and maintenance/update of existing technical files. Ensuring that products are compliant with new and updated requirements. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: Utilizing an intermediate base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to support a focused team. Providing regulatory input to cross-functional teams. Working mostly independently to evaluate regulatory issues and create and revise technical documentation for existing and new regulatory submissions. Preparing regulatory strategies under supervision and authoring draft submissions. Ensuring timeliness of regulatory submissions according to business needs. Assisting with the coordination, preparation, and maintenance of FDA 510(k) filings. Interacting with Regulatory Body personnel under direct supervision. Assisting with upcoming audits and certification reviews. Maintaining Regulatory Affairs product files to support compliance with regulatory requirements. Reviewing promotional and advertising material for adherence to approved product claims and regulatory compliance. Working in partnership with Product Development, Manufacturing, and QA/QC to ensure overall compliance with US and EU directives regulations. Coordinating rollouts of product changes with corporate and international regulatory teams. Coordinating with Regulatory Operations for updates to the Unique Device Identification system. Reviewing Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation. Reviewing labeling for regulatory compliance. Participating in continuous improvement projects within Regulatory Affairs. Contributing to the authoring of SOPs. Performing other duties as assigned. QUALIFICATIONS Bachelor’s degree in science, Engineering, Regulatory Affairs, or other technically related field. Minimum of 2 years related experience in an FDA regulated industry such as Medical Devices, Biotech, or Pharma. Experience in working effectively with cross-functional teams. Awareness of business strategies and tactics, including an understanding of regulatory impact. Proven ability to prepare and submit documents to regulatory agencies, with supervision. Ability to explain regulatory requirements and pitfalls to project teams and colleagues. Detail oriented, well-organized, and able to work both independently and in teams. Understanding of FDA requirements and quality system requirements. Strong writing, project management, and communication skills. Demonstrated skills in contributing to multiple projects simultaneously. Capability to interact with diplomacy and tact while maintaining appropriate assertiveness. Willingness to take ownership and accept responsibility for actions and decisions. Integra LifeSciences is an equal opportunity employer, 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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