Katalyst CRO ยท 3 months ago
Regulatory Affairs Specialist III
Omaha, NE
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is a company focused on regulatory affairs in the medical device industry. They are seeking a Regulatory Affairs Specialist III who will be responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices)
The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards
Develop regulatory strategies to achieve market clearance in an effective and efficient manner
Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU, and other regulatory requirements as applicable:
510(k) and/or De Novo submissions for FDA
Technical documentation for EU MDR compliance
International product registration activities to meet business objectives
Provide regulatory input to support product labeling
Monitor new and changing regulatory requirements and ensure the business understands relevant impacts
Lead corrective and preventive action (CAPA) efforts as assigned
Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions
Assess and document regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations
Qualification
Required
Bachelor of Science degree
57 years of regulatory affairs experience in the medical device industry, preferably with respiratory devices
Current experience leading multiple successful 510(k) clearances and CE marking is required
Strong understanding of medical device product life cycle and regulatory requirements
In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR
Knowledge of ISO 14971 risk management for medical devices
Proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis
Understanding of continuous improvement principles
Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies
Strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions
High level of attention to detail and accuracy, particularly when preparing regulatory submissions
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
Company data provided by crunchbase