Regulatory Program Manager, Med Devices & Biologics

Organogenesis Inc.; Canton (MA); On-site; USD 119,000 - 140,000; Full time

Benefits offered by this job

401k match with immediate vesting

Medical, Dental, and Vision coverage

Flexible Spending Account

Paid maternity and parental leave

Education Assistance Policy

Wellness Program

Employee Assistance Program

Generous PTO

Free parking with EV charging

Discounts

Job summary

Organogenesis Inc. in Canton, MA is seeking a regulatory affairs professional to drive submissions for medical devices and biologics. You will partner with process development, manufacturing and quality to ensure compliant regulatory filings and timely approvals. The role requires at least 5 years in regulatory affairs, BS in science, and experience with PMA, IND, BLA, or 510(k). RAC or advanced degree preferred. Strong communication and project management skills are essential.

Qualifications

• BS degree in science, engineering or math; advanced degree preferred.
• 5+ years of regulatory affairs experience in biotech.
• Experience developing regulatory strategies and submissions.
• Knowledge of PMA, IND, BLA, 510(k).
• Strong written and verbal communication and organizational skills.

Responsibilities

• Develop regulatory strategies and submissions for FDA and international bodies.
• Prepare and file regulatory submissions for medical devices and biologics.
• Collaborate with process development, manufacturing and quality teams.
• Review labeling, advertising materials and MDR/BPDR events.
• Stay updated with QSR, cGMP, ICH, FDA and EU requirements.

Skills

Regulatory affairs

Life sciences

Written/verbal communication

Organizational skills

Project management

Education

BS degree in science/engineering/math

Advanced degree / RAC

Job description

Organogenesis Inc. in Canton, MA is seeking a regulatory affairs professional to drive submissions for medical devices and biologics. You will partner with process development, manufacturing and quality to ensure compliant regulatory filings and timely approvals. The role requires at least 5 years in regulatory affairs, BS in science, and experience with PMA, IND, BLA, or 510(k). RAC or advanced degree preferred. Strong communication and project management skills are essential.