Katalyst CRO · 1 month ago
Regulatory Affairs Specialist
Charlotte, NC
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is a company focused on regulatory compliance in the medical device sector. The Regulatory Affairs Specialist will work with cross-functional teams to ensure regulatory compliance for IVD and laboratory products, while also supporting product registrations and preparing regulatory documentation.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
The Regulatory Affairs Specialist is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality Management System (QMS) to ensure ongoing compliance while continuing to develop regulatory affairs skills
This position reports to the Director, Quality Assurance and Regulatory Compliance (Management Representative) and is part of the Regulatory Compliance team located in Richmond, Illinois and will be onsite
Support product registrations, listings, and renewals globally with the support of Leica partners, and directly in US, Canada, and EU markets, requiring cross-functional and cross-site partnership and execution for new products and change management
Support new product development, design change, and sustainment projects by reviewing and approving design files connected to regulatory compliance, using strong problem solving and decision-making skills
Prepare, review, and approve regulatory documentation for submission, including but not limited to Technical Files and DoCs to regulatory agencies or to commercial partners, and advise on the submission strategy
Control new and change legislations related to Regulatory Affairs activities, actively participating in committees and meetings to discuss new guidance including identifying relevant guidance documents, or consensus standards and providing interpretive assistance
Review and approve Advertising and Promotional Materials (MAPSS) to ensure compliance with regulations in country/countries where materials are distributed, and explain complex information and respond to relevant questions raised during audits
Qualification
Required
Bachelor's degree in science, medical, or technical field or equivalent experience
Minimum of 5 years' experience within medical device/IVD, across a variety of regulatory submissions, compliance initiatives, and cross-functional projects
FDA (Class I & II) and Health Canada regulatory knowledge including registration maintenance, device listings, regulatory requirements, and North America IVD regulatory intelligence
EU (MDR/IVDR) regulatory knowledge including registration maintenance, device listing, regulatory requirements, Importer and Authorized Representative actions
Experience with ISO 13485:2016, IVD/MDR Regulations, FDA GMP and domestic/international Medical Device Regulations
Histopathology / Pathology field
Demonstrated strong communication and collaboration skills across technical and non-technical teams
Using lean manufacturing tools including Danaher Business Systems (DBS) tools to improve quality, processes, and innovation by applying tools and continuous improvement mind-set
Ability to travel - must be able to travel up to 10% of the time, (domestic and international)
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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