Top 628 Lead, optical engineering stray light Jobs in Rochester, Ny

Regulatory Affairs Lead
Kodak —Rochester, NY
- $125,000 - $130,000 a year
- 6 years
- Bachelor's degree
- Mentoring
Customer Sales Lead, Wegmans
Campbell Soup Company —Rochester, NY
- $117,600 - $161,700 a year
- Full-time
- Merchandising
- Mid-level
- Office
- AD&D insurance
- Paid holidays
3d
Lead Product Safety and Compliance Engineer
GE Vernova —Rochester, NY
- $89,300 - $148,700 a year
- Full-time
- 5 years
- Pass drug screening
- Data analysis skills
- Paid parental leave
- Paid holidays
4d
Lead Quality Improvement Specialist
University of Rochester —Rochester, NY
- $94,746 - $142,098 a year
- Full-time
- Clinic experience
- Master's degree
- 8 years
8d
Lead, Optical Engineering
L3Harris Technologies —Rochester, NY
- $117,000 - $218,000 a year
- 7 years
- Laboratory experience
- Analysis skills
- Paid holidays
- Disability insurance
Culinary Arts Project Leader - Uncommon High School
EDceptional —Rochester, NY
- From $75 an hour
- Part-time
- School experience
- Classroom
- High school
- Health insurance
Quick Apply
CNC Lathe Group Leader
D.P. Tool & Machine, Inc. —Avon, NY
- $30 - $40 an hour
- Full-time
- Forklift
- Mentoring
- Power tools
- Health savings account
- Health insurance
Quick Apply
Sr. Team Lead – Hardscape
Josh Landscape Co. —Honeoye Falls, NY
- $32 - $34 an hour
- Overtime
- CDL B
- Construction site
- DOT physical examination
- Opportunities for advancement
Quick Apply
1d
Lead Maintenance Technician
National Property Management Associates Inc —Rochester, NY
- From $25 an hour
- Full-time
- Mid-level
- Residential
- Apartments
- Paid holidays
- Dental insurance
Quick Apply
Production Lead Operator
Seal & Design —Rochester, NY
- $25 - $30 an hour
- Full-time
- Basic math
- Mid-level
- Ability to lift 50 pounds
- Health insurance
- Dental insurance
Quick Apply
Lead Maintenance Technician
National Property Management Associates Inc —Rochester, NY
- From $26 an hour
- Mid-level
- Residential
- Apartments
- Paid holidays
- Dental insurance
Quick Apply
2d
Lead Mammography Technologist
Borg & Ide Imaging —Rochester, NY
- $27.50 - $44.00 an hour
- Full-time
- BLS Certification
- Clinic
- Patient care
- Health savings account
- Health insurance
Engagement Lead
TMP Worldwide India Private Limited for ERS US —Rochester, NY
- $149,000 - $160,000 a year
- Email
- Azure
- Office
- AWS
- AD&D insurance
- Paid holidays
Quick Apply
Maintenance Group Lead
Nortera Foods USA Inc. —Bergen, NY
- $30 - $35 an hour
- Overtime
- Mid-level
- 3 years
- High school diploma or GED
- Health savings account
- Paid holidays
Quick Apply
Commercial HVAC Crew Leader
Beyond TalentEdge —Farmington, NY
- $32 - $48 an hour
- Full-time
- Construction site
- 5 years
- Mentoring
- Health insurance
- Dental insurance
Quick Apply
2d
$2,500 Sign On Bonus Lead Teacher - Browncroft, Irondequoit, & St. Johns
First Learning —Rochester, NY
- $17.50 - $20.50 an hour
- Full-time
- Classroom
- CPR Certification
- Mid-level
- Health savings account
- Health insurance
Quick Apply
Lead Direct Support Professional - Structured Day Program
Empowering People's Independence(EPI) —Rochester, NY
- $19.50 - $24.50 an hour
- Full-time
- Microsoft Word
- Microsoft Excel
- Ability to walk for extended periods
- 403(b) matching
- Health savings account
Quick Apply
2d
Area Lead
Novolex —Canandaigua, NY
- $27.28 an hour
- Overtime
- Microsoft Outlook
- Sanitation
- Mid-level
- Health insurance
- Dental insurance
Lead Diesel Technician - 2nd Shift - $10K Hiring Bonus
Casella Waste Systems, Inc. —Rochester, NY
- $38 - $50 an hour
- Full-time
- CDL B
- 18 years or older
- Customer service
Quick Apply
Lead Maintenance Technician
National Property Management Associates Inc —Rochester, NY
- From $26 an hour
- Full-time
- Mid-level
- Residential
- 3 years
- Paid holidays
- Health insurance
Quick Apply

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lead, optical engineering stray light jobs near rochester, ny

Regulatory Affairs Lead

Kodak -
Rochester, NY

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Job Details

$125,000 - $130,000 a year

Qualifications

Bachelor's degree

Full Job Description

Date: Jun 21, 2026

Location: Rochester, NY, US, 14652

Company: Kodak

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.

EOE Policy Statement:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Estimated Salary: $125,000 - $130,000

Experience Level: 5-10 Years

Requisition ID: 2001

Apply Now

Refine Your Search

lead, optical engineering stray light jobs in rochester, ny

Regulatory Affairs Lead

Customer Sales Lead, Wegmans

Lead Product Safety and Compliance Engineer

Lead Quality Improvement Specialist

Lead, Optical Engineering

Culinary Arts Project Leader - Uncommon High School

CNC Lathe Group Leader

Sr. Team Lead – Hardscape

Lead Maintenance Technician

Production Lead Operator

Lead Maintenance Technician

Lead Mammography Technologist

Engagement Lead

Maintenance Group Lead

Commercial HVAC Crew Leader

$2,500 Sign On Bonus Lead Teacher - Browncroft, Irondequoit, & St. Johns

Lead Direct Support Professional - Structured Day Program

Area Lead

Lead Diesel Technician - 2nd Shift - $10K Hiring Bonus

Lead Maintenance Technician

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