Mass General Brigham · 1 month ago
Regulatory Affairs & Compliance Manager, PET Production Facility
Boston, MA
Full-time
Onsite
Mid, Senior Level
$98K/yr - $142K/yr
3+ years expMass General Brigham is a not-for-profit organization focused on advancing patient care, research, teaching, and community service. They are seeking a Regulatory Affairs & Compliance Manager for their PET Production Facility, responsible for overseeing compliance with FDA regulations and leading quality improvement initiatives within the facility.
Health CareHome Health CareMedical
Responsibilities
Authors and reviews of standard operating procedures, technical reports, and other cGMP documents
Educates staff and organizational members and project participants on quality improvement methodologies and tools
Provides leadership and hands-on participation in projects to develop quality improvement skills
Develops a quality improvement culture with staff and leaders to support organizational development
Maintains an updated library of FDA regulations and guidance documents
Performs annual product quality review for each radiopharmaceutical
OOS investigation coordination
Change control management
CAPA management and verification of efficacy
Vendor complaint handling
Assists with IND submissions, annual reports, amendments, etc
Maintain inspectional readiness
Tracking and trending data related to investigations, environmental monitoring, production
Record keeping maintaining compliance with the following regulatory authorities:
Massachusetts Department of Public Health
Massachusetts Board of Pharmacy
Food and Drug Administration
Radiation Safety Department
Hospital Policies
Collaboration with PET Production/Cyclotron staff in the performance of quality investigations
Maintaining a positive working relationship with vendors and hospital service providers (e.g. Buildings and Grounds)
Documentation of facility repairs
Calibrated equipment inventory management
Equipment IQ/OQ documentation review
Documentation management per institution document control policy
Leads improvements to quality management system
Serves as liaison between industry partners and facility for collaboration work
Oversees personnel training program and documentation
Qualification
Required
Bachelor's degree required
3 – 5 years of direct experience in a pharmaceutical manufacturing field
2-3 years supervisory experience
Preferred
Certification in quality management or other cGMP certification
Regulatory Affairs
Pharmaceutical Science, manufacturing, or other related field
5 – 10 years of direct experience in a pharmaceutical manufacturing field
Professional certification
Benefits
Comprehensive benefits
Career advancement opportunities
Differentials
Premiums and bonuses as applicable
Recognition programs designed to celebrate your contributions and support your professional growth
Company
Mass General Brigham
Mass General Brigham specializes in providing medical treatments and health diagnostics services.
10001+ employees
H1B Sponsorship
Mass General Brigham has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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Trends of Total Sponsorships
2025 (77)
2024 (61)
2023 (93)
2022 (70)
2021 (80)
2020 (29)
Funding
Current Stage
Late StageLeadership Team
E
Erin Flanigan
SVP, Human Resources, Community, Specialty Hospital Division
O’Neil A. Britton
Chief Integration Officer, Executive Vice President
Recent News
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