Regulatory Affairs Specialist

Job Description:We are looking for a Regulatory Affairs Specialist to join our team. The Regulatory Affairs Specialist provides leadership and input on company strategies and programs involving regulatory and government agencies; helps to develop strategies to ensure regulatory requirements are met; determines requirements, then compiles and files applications for sale of Innovasis products with regulatory and government agencies; provides regulatory input to project teams; plans and implements policies, procedures, practices, and strategies for Regulatory Affairs. The position provides backup for interfacing with regulatory bodies and/or Auditing Organization(s).Responsibilities: Assists in developing the company's quality management system in compliance with all relevant standards and regulations. Prepares appropriate technical, quality, manufacturing, and regulatory data and documentation for the purpose of supporting QMS certification and developing regulatory submissions to U.S. FDA and applicable foreign regulatory bodies. Prepares and submits regulatory filings, such as FDA 510(k) and other domestic and foreign/Outside U.S. (OUS) regulatory filings, submissions, and trademarks. Prepares and maintains documentation (e.g., Technical Files) to support OUS product registrations and licensing. Identifies key activities for regulatory goals for assigned project teams and sets clear targets to achieve results. Maintains a professional and credible image with FDA, Auditing Organization(s), foreign partners/representatives and OUS regulatory agencies. Keeps abreast of ongoing regulatory changes and new regulations. Aids in analyzing proposed new and/or changed regulations, their impact to the company's products and processes and assesses their implications to the company's current and future business activities. Collaborates with R&D Engineering, Manufacturing, Marketing and Quality Functions as needed to execute regulatory strategy throughout Total Product Lifecycle (TPLC). Aids in identifying quality issues and developing corrective and preventive action plans. Monitors product labels and labeling to ensure compliance with relevant standards and regulations. Develops and provides training to selected staff relative to the requirements of regulatory and/or QMS matters. Reviews and approves MedWatch and Vigilance reports. Leads product advisory/recall activities and coordinates with regulatory authorities. Provides regulatory review and approval of technical and QMS documentation. Requirements: Bachelor's degree in biology, Engineering, Degree in other fields may be considered depending on the degree field and experience/relevance within the medical device industry. Regulatory training, including FDA and ISO regulatory compliance and submission. Quality training, including auditing, validation, design control, etc. ASQ, RAPS, or other nationally recognized certification preferred. Demonstrated experience in the preparation of regulatory submission applications such as 510(k), CE mark, Canada license, TGA registration, Brazil ANVISA applications, etc. Experience may be considered in lieu of completed academic degree. Experience with Design Control teams and other interactions with Engineering. Experience with data analysis reporting.