Regulatory Affairs Specialist III
Katalyst Healthcares and Life Sciences
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
- Product Development Support:
- Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions
- Change Control Management:
- ssess and document regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations
- udits and Inspections:
- Support and participate in internal and external audits and regulatory agency inspections
- Complete QMS training activities and provide regulatory expertise to continuous improvement activities
- Support Lean and Kaizen initiatives
- Comply with all company policies and procedures
- ssist with any other duties as assigned
- Bachelor of Science degree
- 5-7 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
Vacancy posted 2 days ago
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