Description Job Title: Regulatory Affairs Specialist Department: Regulatory Reports To: Director of Regulatory Affairs FLSA Status: Exempt Supervise the work of others: No Position Summary: This position is responsible for preparing submissions to various regulatory agencies. Additionally, the position will help maintain and improve upon domestic and international compliance. Candidate must possess the ability to work well in a team environment and demonstrate great attention to detail. Duties and Responsibilities: This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties may be assigned. • Prepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies, including FDA, Notified Bodies, and Authorized Representatives. • Prepare, maintain, and submit, when necessary, European Medical Device Directive and European Medical Device Regulation compliant Technical Files. • Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards. • Work with the international department on various regulatory filings for product registration in different countries. • Provides regulatory support for other projects as required. • Updating appropriate personnel on new and revised processes and procedures. · Process, execute, organize and archive various internal documentation related to Engineering and/or Quality Systems. · Preparing change order documentation and routing it for final approval. Supervisory Responsibilities: None 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience: · Minimum of 2 year college degree, Bachelor’s Degree (or greater) preferred. · Relevant work experience, preferably in the medical or legal field and/or other regulated industry. · Previous experience creating and revising labels and DFUs preferred. · Knowledge of European, ISO 13485 and FDA regulations preferred. · Knowledge of international regulatory guidelines regarding GMP requirements is desirable. Language/Communication Skills: Ability to communicate across functions, professional levels and background. Computer Skills: Intermediate to advanced knowledge of Microsoft Office Suite. Essential Job Functions: Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons. Mental: Must be able to effectively communicate with others; complete and understand complex situations, analysis of numbers; read, analyze and interpret written materials; work with team to meet and exceed company standards; ensure compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems. Physical: Must be able to communicate for hours at a time, use computer equipment. Moderate noise level and limited exposure to physical risk. Knowledge, Skills, and Abilities Required: Knowledge of modern business communication, office procedures and methods. Skill to use a personal computer and various software packages such as Microsoft Office Suite. Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork. Equipment Used: Telephones, computer, other office equipment as needed. Special/ Additional Requirements: Persons in this position may be required to pass a drug, alcohol, and/or criminal background check. Requirements 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience: · Minimum of 2 year college degree, Bachelor’s Degree (or greater) preferred. · Relevant work experience, preferably in the medical or legal field and/or other regulated industry. · Previous experience creating and revising labels and DFUs preferred. · Knowledge of European, ISO 13485 and FDA regulations preferred. · Knowledge of international regulatory guidelines regarding GMP requirements is desirable.