Sr. Regulatory Affairs Specialist

Sr. Regulatory Affairs Specialist

Research and present regulatory pathways for product development and global expansion efforts to regulatory management. Such key elements for research and recommendation would include product classification and regulatory justification, regulatory precedence/review of other products in class, designation, governing laws and regulations, applicable guidance documents, and submission type anticipated. Participate on project teams to define regulatory requirements in the U.S. and internationally. Determine and sign off on MDR decision trees, acting as the liaison with regulatory authorities, and 510(k) decision tree determination. Prepare comprehensive 510(k) submissions to the FDA, as well as responses to FDA letters, supplemental requests, and amendments. Compile robust product Technical Files for competent authorities and other regulatory authorities in the EU, Canada, and other countries, in accordance with established requirements and guidance documents; prepare responses to requests for information; and update documentation when appropriate, and in a timely manner. Manage timelines for 510(k) submission/Technical File documentation, such as technical protocols and reports; support with the preparation of additional documentation as needed. Review DCOs that impact product such as for changes in manufacturing facilities, manufacturing procedures, and analytical methods, and generate Letters to File following FDA-Ts decision tree guidance on when to file for a 510(k). Maintain product licenses and registrations in current status. Identify guidance documents, international standards and consensus standards and assist product development teams with their interpretation. Analyze and make recommendations regarding complaints received. Determine whether they are MDR or vigilance reportable; participates in complaint investigations and CAPA meetings as appropriate. Act as liaison with local, national and international regulatory authorities. Write and maintain Standard Operating Procedures (SOPs) for Regulatory and Clinical functions. Maintain Clinical documentation in FDA inspection ready status. Perform GCP audits as assigned. Keep informed of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company. Provide regulatory training when needed. Related Regulatory and Quality System support as needed