Katalyst CRO · 2 months ago
Regulatory Affairs Manager
San Francisco, CA
Contract
Onsite
Senior Level, Lead/Staff
8+ years expKatalyst CRO is seeking a Regulatory Affairs Manager to lead regulatory strategies and submissions for medical devices. The role involves collaboration with various teams and direct interaction with the FDA to ensure compliance with regulatory requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop and execute U.S. regulatory strategies to support product submissions (e.g., IDE, 510(k), De Novo) and post-market requirements
Serve as the primary point of contact with the U.S. Food and Drug Administration (FDA) and their regulatory agencies, leading meetings, Q-Subs, and communications
Collaborate with cross-functional teams (R&D, Clinical, QA, Manufacturing) to align regulatory strategies with product design, testing, and commercialization plans
Prepare, review, and manage regulatory submissions, technical files, and design dossiers for U.S. and global markets
Interpret and communicate regulatory requirements, guidance, and changes (e.g., 21 CFR Parts 807, 812, 814, 820; ISO 13485; ISO 14971; MDR)
Ensure labelling, advertising, and promotional materials comply with FDA regulations and company policies
Support quality and clinical teams in pre-submission meetings, audits, and inspections
Monitor evolving U.S. and international regulatory landscapes, providing proactive recommendations to management
Develop and maintain relationships with regulatory consultants, testing labs, and external partners
Provide regulatory training and mentoring to internal stakeholders
Qualification
Required
Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field (master's preferred)
Minimum of 8 years of regulatory affairs experience in the medical device industry (preferably Class II/III)
Demonstrated experience with FDA submissions (510(k), IDE, or PMA) and direct interaction with FDA reviewers
Solid understanding of U.S. FDA regulations, QSR (21 CFR Part 820), ISO 13485, ISO 14971, and related standards
Excellent written and verbal communication skills in English, with the ability to represent the company professionally before regulatory bodies
Preferred
Experience with software-enabled or wearable medical devices
Knowledge of EU MDR and international submissions (e.g., Canada, Australia, Japan)
RAC (U.S.) certification or equivalent professional credential
Bilingual (English and Mandarin) a plus but not required
Strong problem-solving, strategic thinking, and organizational skills suitable for a fast-paced startup environment
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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