Sr. RA Specialist

About The Team

Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together!

A Day In The Life Of Our Sr. RA Specialist

• Regulatory Strategy & Product Development
• Support development and execution of global regulatory strategies for new and existing medical devices.
• Provide regulatory guidance to cross-functional teams throughout product development, design changes, and sustaining engineering activities.
• Assess regulatory impact of product, process, labeling, software, and manufacturing changes.
• Participate in design reviews and product development activities to ensure regulatory requirements are incorporated.
• Regulatory Submissions & Registrations
• Prepare and submit regulatory submissions including FDA 510(k)s, international registrations, technical documentation, and other regulatory filings as required.
• Support compilation and maintenance of Design and Development Files (DDF), Technical Documentation, and regulatory submission dossiers.
• Coordinate submission activities with regulatory agencies, notified bodies, and international regulatory authorities.
• Track submission status and ensure timely responses to regulatory inquiries.
• Regulatory Compliance
• Monitor and interpret evolving regulatory requirements and standards, including FDA, EU MDR, ISO 13485, MDSAP, and other applicable regulations.
• Ensure ongoing compliance with global regulatory requirements throughout the product lifecycle.
• Support implementation of new regulatory requirements within the Quality Management System (QMS).
• Maintain product registrations, licenses, and regulatory approvals.
• Labeling & Promotional Review
• Review product labeling, Instructions for Use (IFUs), marketing materials, and promotional content for regulatory compliance.
• Ensure claims are adequately supported and consistent with approved regulatory submissions.
• Audits & Inspections
• Support internal audits, external audits, notified body assessments, and regulatory inspections.
• Provide regulatory subject matter expertise during audits and inspections.
• Assist in developing responses to audit findings and regulatory observations.
• Cross-Functional Collaboration
• Collaborate with Quality, Product Development, and Manufacturing teams to support regulatory objectives.
• Support complaint investigations, CAPAs, post-market surveillance, and field actions from a regulatory perspective.
• Participate in management reviews and regulatory compliance reporting activities.
• Regulatory Intelligence
• Monitor industry trends, regulatory changes, guidance documents, and standards updates.
• Communicate regulatory changes and assess business impact.
• Recommend actions to maintain compliance and support business objectives.

About You

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related technical discipline. Advanced degree preferred.
• 5+ years of Regulatory Affairs experience within the medical device industry.
• Experience preparing and supporting FDA 510(k) submissions.
• Experience supporting international registrations and regulatory submissions preferred.
• Working knowledge of medical device development processes and design controls.
• Experience with Class II and/or Class III medical devices preferred
• Strong knowledge of: FDA 21 CFR Part 820 and applicable FDA regulations, EU MDR (2017/745), ISO 13485, ISO 14971 Risk Management, MDSAP requirements, Medical device labeling requirements
• Regulatory Affairs Certification (RAC) preferred.
• Experience with software-enabled medical devices and cybersecurity submissions preferred.
• Experience supporting global markets including EU, Canada, Australia, and Asia-Pacific regions.
• Experience interacting directly with FDA, notified bodies, and international regulatory agencies
• Strong project management and organizational skills.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently with minimal supervision.
• Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS)

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