Katalyst CRO ยท 2 months ago
Regulatory Affairs Specialist II
Alameda, CA
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is a company specializing in clinical research services, and they are seeking a Regulatory Affairs Specialist II to manage regulatory submissions for medical devices in the U.S. and Europe. This role involves providing regulatory guidance throughout the product development cycle and ensuring compliance with all regulatory requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail
Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation
Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications
Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc
Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal 'Non-Filing Justifications (U.S.) for changes that do not require a 510(k) submission
Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.)
Submit notifications to the EU Notified Body for significant changes to CE marked products
Maintain Regulatory documentation
Support special projects, as needed
Qualification
Required
Bachelor's degree (Engineering, Biology, or Regulatory Science) and a minimum of 3+ year(s) related experience; or equivalent combination of education and experience
Proven experience with software as a medical device (SaMD) and mobile health app regulations
In-depth knowledge of FDA guidance on digital health, cybersecurity, and mobile medical apps
Track record of 510(k)/De Novo submissions for connected orthopedic or wearable devices
Familiarity with IEC 62304, ISO 13485, and FDA Part 11 compliance for software validation
Experience with EU MDR requirements for software and app-based devices (Annex I & XIII)
Effective collaboration with software, clinical, and human factors teams
Post-market compliance expertise, including UDI, vigilance, and software change reporting
Strong understanding of cybersecurity requirements and guidance (e.g., FDA, IMDRF)
Knowledge of US and/or international regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.)
Direct experience with regulatory submissions for Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML) products
Excellent attention to detail and proven organizational skills, able to prioritize and multi-task and see projects/assignments to completion
Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems
Proven leadership and negotiation skills, works well with all levels, able to successfully manage cross-departmental expectations
Excellent written and verbal communication skills
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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