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.

* 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.