We are hiring a Regulatory Affairs Lead within our Kodak Pharmaceuticals group in Rochester, NY. This individual is responsible for establishing, managing, and executing regulatory strategies to support a growing medical device organization as it evolves toward pharmaceutical and combination product development. This role provides hands-on regulatory leadership for FDA submissions, clinical studies, and product lifecycle management, while helping build scalable regulatory processes aligned with FDA medical device, drug, and combination product requirements. Responsibilities: Regulatory Strategy & FDA Submissions - Develop and execute U.S. regulatory strategies for medical devices with alignment to future pharmaceutical and combination product pathways. - Prepare, submit, and manage FDA 510(k) submissions, including traditional, special, and abbreviated submissions. - Lead regulatory impact assessments for design changes, labeling updates, and manufacturing process changes. - Manage FDA interactions including Q-Submissions, deficiency responses, meetings, and ongoing correspondence. - Support regulatory submissions in global markets as required. Clinical Studies & Development Support - Provide regulatory oversight and support for clinical investigations, including IDE preparation, regulatory assessments, and FDA communications. - Review and support clinical protocols, informed consent forms, and clinical study reports for regulatory compliance. - Partner with Clinical, R&D, and Quality teams to ensure regulatory requirements are incorporated into study design and execution. Combination Product & Early Pharmaceutical Readiness - Support regulatory planning for combination products and future pharmaceutical development in alignment with FDA drug, device, and combination product regulations. - Provide regulatory input on product classification, primary mode of action, and applicable regulatory pathways. - Assist in establishing regulatory infrastructure and documentation practices suitable for drug and combination product development. Quality System & Compliance - Ensure regulatory compliance with applicable FDA requirements including 21 CFR Parts 820, 807, 803, 812, and applicable drug regulations as they emerge. - Maintain regulatory documentation in alignment with the Quality Management System (QMS) and ISO 13485. - Support internal audits, external audits, and FDA inspections as needed. Cross-Functional Leadership - Collaborate with Engineering, R&D, Manufacturing, Quality, Clinical, and Marketing teams to ensure regulatory requirements are understood and implemented. - Review product labeling, promotional materials, and technical documentation for regulatory compliance. - Provide clear regulatory guidance and risk-based recommendations to cross-functional stakeholders and leadership. Process Development & Continuous Improvement - Develop, implement, and improve regulatory processes, templates, and procedures to support organizational growth. - Monitor changes in FDA regulations, guidance documents, and industry standards and assess impact on existing and future products. - Mentor and support junior regulatory staff or project team members as the organization scales. Qualifications (Education, Experiences and Skills): - Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field required. - 6–8 years of Regulatory Affairs experience within the medical device industry. - Demonstrated hands-on experience preparing and submitting FDA 510(k) applications. - Experience supporting clinical studies and IDE-related activities. - Strong working knowledge of FDA medical device regulations and Quality System requirements. - Exposure to pharmaceutical, drug device combination products, or early drug development strongly preferred. - Excellent written, verbal, and interpersonal communication skills. - Strong organizational skills and ability to manage multiple projects in a fast-paced, growing environment. - Ability to think strategically while executing detailed regulatory activities.