Regulatory Affairs Specialist

Long Term Success, we know what it means. Since 1987, 3I has been at
the forefront of the oral reconstructive industry, with affiliates in
30 countries worldwide. Located in Palm Beach Gardens, 3I is a world
leader in the manufacture and sale of dental implants and devices.
3i is an Equal Opportunity Employer.


Summary: Support Regulatory Affairs Manager and be responsible for all aspects of product development and premarket submissions, and ensuring company compliance with FDA regulatory requirements.

Essential Duties and Responsibilities:
•Create and implement strategies independently or with multifunctional teams for the completion of the project.
•Create and submit premarket notifications [510(k)] or rationale for not filing to support the release of new or modified products.
•Review and approval of all labeling including promotional material before publication and/or release.
•Develop and implement procedures for the Regulatory Department.
•Participate in teams that handle problem reports, corrective action, trending and preventative actions.
•Review and approve document/design change requests (DCRs) with appropriate determinations and documentation for both domestic and international registrations.
•Support the company during inspections/audits and label review assessments by the FDA, notified bodies or other international regulatory bodies.
•Review and approval of custom device applications, providing appropriate regulatory determinations and documentation.
•Update and maintain all regulatory files, device listings and facility registrations.
•Other duties and special projects as assigned.

Supervisory Responsibilities: None.
REQUIREMENTS
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions to perform this job. The individual must demonstrate an in-depth working knowledge of FDA and regulations and how to interpret them and knows where to monitor regulations for changes. This individual may also demonstrate some knowledge of international regulations as well.

Education and/or Experience: Minimum Bachelors degree in health or science related filed. Minimum of three (3) years of practical medical device regulatory experience; or posses the equivalent combination of education and experience. Familiar with US federal regulations. Must have analytical skills, be detail oriented and have good interpersonal skills. Must have the ability to use a personal computer and software including word processing and spreadsheets. Must be a self-starter, flexible and adaptable; capable of handling multiple projects simultaneously. Previous experience in regulatory in a dental medical device company is preferred, but not necessary.

Language Skills: Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management and Team Members.

Mathematical Skills: Ability to apply mathematical operations to such tasks as frequency distribution, analysis of variance, correlation techniques, and factor analysis.