Katalyst CRO ยท 1 month ago
Regulatory Affairs Specialist II
Irvine, CA
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is a company focused on regulatory affairs for medical devices, and they are seeking a Regulatory Affairs Specialist II. The role involves preparing regulatory submissions for marketing medical devices in the U.S. and Europe, supporting international product registrations, and ensuring compliance with regulatory requirements throughout the product development process.
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
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
B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry
2-5 years Medical Device experience
Working knowledge of industry consensus standards and FDA guidance is required
At least 2 years Regulatory Affairs experience in Medical Device regulations
Demonstrated success in taking products through FDA and EU Notified Bodies
Working knowledge of 510(k), MDD 93/42/EEC
Regulatory Affairs Certified RAC (RAPS)
Proficient in using Microsoft Office
Strong communication and project management skills
Must be able to handle multiple tasks
Attention to detail
510(k), MDR
21 CFR 820 - Quality System Regulation, ISO 13485
Medical device standards and FDA guidance relevant to medical devices
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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