Sr. Regulatory Affairs compliance Manager

Sr. Regulatory Affairs Compliance Manager (Project Management) We are hiring for a Sr. Regulatory Affairs Compliance Manager. The Senior Regulatory Affairs Compliance Manager is responsible for domestic and international regulatory compliance for Patient Safety medical devices and personal protective equipment designed and/or manufactured at TIDI Products, LLC, including enterprise compliance processes involving licensing and accreditation. The role begins at the product design phase to provide early guidance on regulatory requirements. This is a key leadership position that models and deploys TIDI's mission, core values, and guiding principles. Essential responsibilities: Support the Director of Regulatory Affairs on domestic and international regulatory issues. Conduct regulatory assessments and participate in project teams to guide regulatory strategy, review labeling, and promotional materials for new and modified products under Posey Products, excluding devices containing software. Coordinate international registration of TIDI Posey products. Manage regulatory issues for non-electronic medical devices and PPE, providing early guidance during product design, including submissions, claims, labeling, and compliance validation. Lead and develop a team of 2-3 direct reports, including training and delegation of responsibilities. Develop and implement procedures ensuring compliance with US and international regulations. Oversee GUDID/EUDAMED submissions and maintain regulatory databases. Perform US and international regulatory assessments for new and modified products. Handle international registration submissions and maintain EU technical files and design dossiers. Participate in project teams for design control reviews and regulatory strategies, coordinating assessments with consultants as needed. Coordinate certificates, foreign government approvals, and notarizations. Review and approve labeling for compliance with US, MDSAP, and EU requirements. Manage regulatory data, registrations, and listings, including FDA and Health Canada. Lead regulatory aspects of field actions and import issues with FDA. Maintain state licensing, accreditation, and law label requirements for all TIDI facilities and products. Develop and maintain regulatory databases for TIDI products. Evaluate and implement compliance procedures and train staff on company values and regulatory standards. Qualifications: Thorough understanding of FDA and EU UDI requirements and databases. Knowledge of Customs Export/Import processes. Experience with Prescription Medical Devices and licensing. Understanding of international registration requirements. Familiarity with ISO 13485, ISO 14971, MDSAP, and related standards. Bachelor's or Master's in Engineering, Science, or clinical field. Minimum 7 years in Regulatory Affairs, Quality, or Engineering/Product Development. Management or team leadership experience. Knowledge of design controls, RAPS/ASQ certifications preferred. Strong decision-making, strategic planning, and leadership skills. Excellent communication skills. Additional information: We offer comprehensive benefits and are committed to diversity and inclusion. The estimated salary range is $145,000 - $160,000, with a competitive benefits package.

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