Regulatory Affairs Specialist

Regulatory Affairs Specialist

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.