Regulatory Affairs Lead

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.