Organogenesis · 1 day ago
Program Manager, Regulatory Affairs
Canton, MA
Full-time
Onsite
Mid, Senior Level
$119K/yr - $140K/yr
5+ years expOrganogenesis is a company dedicated to providing healing solutions that improve lives while lowering healthcare costs. The Program Manager in Regulatory Affairs will be responsible for managing regulatory requirements for medical devices and biologics, developing regulatory strategies, and ensuring compliance with relevant regulations. This role involves collaboration with various departments to prepare domestic and international regulatory submissions and provide regulatory support for product changes.
BiotechnologyHealth CareManufacturingMedical
Responsibilities
Working closely with process development, manufacturing and quality departments to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing, and editing technical reports and regulatory documentation
Providing input on and review of protocols and reports including but not limited to process validation, equipment qualification, and shelf-life studies
Ensuring regulatory compliance with QSR and cGMP requirements and stay apprised of ICH, FDA and EU requirements
Evaluating changes to determine the filing requirements and impact on AATB certifications, state licenses, and FDA registrations
Review of labeling changes, and advertising and promotional material
Review of complaints for medical device reporting (MDR) requirements
Qualification
Required
BS degree is required with a degree in science, technology, engineering, or mathematics preferred
A minimum of 5 years of relevant experience in the biotech industry required; a minimum of 3 years of experience in developing regulatory strategies, planning and preparing regulatory submissions required
Regulatory experience with development of Medical Device and Biologic products required, including PMA, BLA and/or 510(k)
Must have a good working knowledge of relevant regulations and industry standards
Strong organizational, interpersonal and written/verbal communication skills required
Experience with technical aspects of product development and manufacturing
Preferred
Experience with regulatory product lifecycle management preferred
Working knowledge of FDA and International Biologics/Drug/Device regulations is preferred
In addition, prior experience with medical devices development and registrations is a plus
Ability to prioritize and multi-task projects independently is preferred
Benefits
401k -- generous employer match with immediate vesting and financial planning resources
Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
Paid maternity leave and parental leave for all new parents
Adoption benefits
Education Assistance Policy - $5,000 per year for all employees
Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
Employee Assistance Program
Generous paid time off including vacation, floating holidays, sick days, and company holidays
Free parking including an electric charging station (Canton and La Jolla)
Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint
Company
Organogenesis
Organogenesis Inc. is a regenerative medicine company.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$614.7MKey Investors
Silicon Valley BankEastward Capital Partners
2024-11-27Post Ipo Equity· $130M
2021-08-09Debt Financing· $200M
2020-12-02Post Ipo Equity· $64.7M
Leadership Team
M
Michael Catarina
Chief Technology Officer
David Francisco
Chief Financial Officer
Recent News
2026-01-09
MarketScreener
2025-12-24
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