Regulatory Affairs Engineer
Innovative Health LLC
Summary
The Regulatory Affairs Engineer role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies.
Job description
- Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product
- Provides documentation and support for the submission/maintenance of regulatory documents for international regulatory bodies
- Reviews complaints/adverse events for submission of MDRs
- Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information
- Participate in project development teams and review plans, reports, risk management, risk assessments and design reviews associated with product and process projects
- Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities
- Participates in internal/external audits and prepares responses to support audit findings or other respective actions related to such audits
- Conduct regulatory review and approval of change orders, CAPA/nonconformance, and related project documentation
- Assist with label and IFU development and review for compliance before release
- Review promotional material to ensure compliance with applicable regulations
- Implement and maintain unique identifier (UDI) activities for implementation/compliance
- Assists with FMEA risk assessments
- Maintain and disseminate current knowledge base of existing regulations, standards, or guidance documents and proactively seek and find information to help resolve questions related to assigned projects
- Develops and implements company policies and procedures
- Assists in archiving regulatory documentation and maintaining related repository
Qualifications
- Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field)
- Experience and knowledge of FDA 21 CFR Part 820 and 510K submission requirements
- Experience and knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards preferred
- Minimum of three years medical device experience
- Working knowledge of QMS systems and functionality
- Previous 510(k) submissions; preferred
- Ability to work in a fast paced, collaborative team environment
- Ability to handle multiple projects and coordinate cross functional teams
- Ability to communicate effectively with management, direct reports and external vendors
- Ability to write technical documents (procedures, test methods, protocols and reports)
- Ability to recommend technical solutions
- Ability to specify regulatory requirements for products
- Ability to work with little supervision
- Ability to use personal computers including software such as: Word, PowerPoint, Excel, Project and Minitab
- Self-starter and highly motivated
Requirements
- Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field)
- Experience and knowledge of FDA 21 CFR Part 820 and 510K submission requirements
- Minimum of three years medical device experience
- Working knowledge of QMS systems and functionality
- Ability to work in a fast paced, collaborative team environment
- Ability to handle multiple projects and coordinate cross functional teams
- Ability to communicate effectively with management, direct reports and external vendors
- Ability to write technical documents (procedures, test methods, protocols and reports)
- Ability to recommend technical solutions
- Ability to specify regulatory requirements for products
- Ability to work with little supervision
- Ability to use personal computers including software such as: Word, PowerPoint, Excel, Project and Minitab
- Self-starter and highly motivated
Company overview
Innovative Health LLC is an advanced, FDA-regulated medical device reprocessing company specializing in electrophysiology and cardiology devices. Founded in 2015 by reprocessing industry pioneers, the company focuses on developing innovative technologies to safely reprocess single-use medical devices used in cardiac procedures. Based in Scottsdale, Arizona, Innovative Health has established itself as a leader in the medical device reprocessing sector with over 50 FDA clearances for reprocessing complex electrophysiology devices. The company's core mission is to help hospitals and electrophysiology labs significantly reduce procedure costs by offering reprocessed single-use devices at substantially lower prices, enabling healthcare facilities to adopt newer technologies, improve patient care, and expand services. With a specialized focus on cardiology devices, including mapping catheters, diagnostic ultrasound catheters, and transseptal needles, Innovative Health employs advanced R&D capabilities and maintains collaborative partnerships with leading hospitals across the United States. The company's science-driven approach and guaranteed savings programs have positioned it as a key player in addressing healthcare cost challenges while maintaining patient safety and regulatory compliance.