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　　JOB SUMMARY

　　The regulatory affairs project manager will support the on-going development, maintenance, and expansion of the Regulatory Information Management System (RIMS). This role requires the functional understanding of regulatory requirements and the ability to perform database analysis, data and document uploads, and verification to support the Global Regulatory Affairs function, as well as Integra LifeSciences. The role requires knowledge of U.S. and International requirements as defined in US Food and Drug Administration regulations, ISO 13485 Standard, European Medical Device Directives (93/42/EEC), European Medical Device Regulation (2017/745), Canadian Medical Device Regulations, Japanese QMS Ordinance (Ministerial Ordinance No. 169), Australian Therapeutic Goods (Medical Devices) Regulations 2002 (No. 236) and other International Regulations.

　　To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

　　Collaborate with Information Systems department and act as data expert for the Regulatory Information Management System (RIMS).

　　Serve as a RIM System Business Administrator

　　Obtain, review, organize, interpret, and verify data from regulatory documents and submissions for entry into the RIM system.

　　Manage regulatory data and the associated documents as required (e.g., Certificates, Licenses, etc.).

　　Collaborate on loading and archiving of regulatory documents.

　　Generates, monitors, and executes project management plans and timelines; prepare status reports and conduct meetings to follow-up on issues.

　　Generate RIMS reports for internal customers.

　　Monitor UDI database requirements and regulations (e.g., EUDAMED).

　　Participates in regulatory initiatives and special projects to facilitate overall regulatory compliance.

　　Develops regulatory process expertise and provides information on regulations.

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

　　Assists with internal and external compliance programs, audits and site inspections by federal and international regulatory agencies.

　　Develops new regulatory policies, processes and SOPs and provides training.

　　Performs all other related duties as directed by manager.

　　DESIRED MINIMUM QUALIFICATIONS

　　To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and abilities to perform the job is acceptable.

　　Proficient use of Microsoft Office, Word, Excel, PowerPoint, Visio

　　Must be project oriented requiring minimal supervision

　　Must possess excellent communication skills both verbal and written

　　EDUCATION/ EXPERIENCE

　　Bachelor’s degree with 3 to 5 years of experience, and/or equivalent combination of education and experience, in preparing regulatory submissions for device and/or drug, biologic products.

　　Must have ability to prepare and submit documents to FDA, such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), and Premarket Approval Applications, (PMAs), Investigational New Drug (IND), or New Drug Applications (NDA).

　　Must possess and demonstrate an understanding of FDA Regulations, ISO 13485 Standard, European Medical Device Directives/Regulations, Canadian Medical Device Regulations, Japanese QMS Ordinance (Ministerial Ordinance No. 169), Australian Therapeutic Goods (Medical Devices) Regulations 2002 (No. 236), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) RDC 16/2013 and other International Regulations.

　　Must have strong writing, project management and communication skills.

　　ADDITIONAL DETAILS

　　This role is hybrid with three days onsite in Princeton, NJ and two days remoteIntegra 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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected] or call us at 855-936-2666.

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