Regulatory Affairs Lead

Responsibilities

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.