Katalyst CRO · 1 day ago
Associate Regulatory Affairs Manager
Boulder, CO
Contract
Onsite
Mid Level
4+ years expKatalyst CRO is a company focused on regulatory affairs for medical devices and IVD products. They are seeking an Associate Regulatory Affairs Manager to support the development and submission of regulatory documents while ensuring compliance with global regulations.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
The Associate Regulatory Affairs Manager will support the development, review, and submission of regulatory documents for medical device and IVD products
This role will assist in managing regulatory projects, ensuring compliance with FDA, ISO 13485, and other global regulatory requirements
The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle
Assist in the preparation, review, and submission of regulatory documentation for new products, product changes, and ongoing compliance
Support the regulatory submission process for 510(k), Technical Files, and other regulatory filings
Provide regulatory guidance to cross-functional teams during product development and post-market activities under the direction of senior management
Help track and manage submission timelines, regulatory project plans, and documentation
Stay informed on changes in FDA, ISO 13485, IVDR, and other global regulations, communicating relevant updates to the team
Conduct regulatory assessments for product modifications and assist in defining appropriate submission strategies
Participate in internal and external audits, inspections, and regulatory agency communications as assigned
Contribute to the maintenance of regulatory files and submission records in accordance with internal procedures and regulations
May provide oversight and mentorship to junior staff or specialists on assigned projects
Qualification
Required
Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field
46 years of regulatory affairs experience in the medical device or IVD industry
Experience supporting or managing 510(k) submissions and regulatory filings
Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and international medical device regulations
Strong organizational, document management, and project coordination skills
Excellent communication, problem-solving, and cross-functional collaboration abilities
Detail-oriented with the ability to manage multiple regulatory projects and priorities
Proficient in Microsoft Office and regulatory document management systems
Ability to work independently and proactively while seeking guidance for complex issues
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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