Director Regulatory Affairs and Quality Assurance

OXOS Medical, Inc. empowers every provider with the capability, clarity, and confidence to make accurate decisions at the point of care. We are building new kinds of radiographic imaging devices that push the boundaries of previous solutions by improving image quality, reducing radiation exposure, improving ease of use, and building solutions to deliver care outside of traditional scenarios. We enable anyone anywhere to access radiologic diagnostics at the point of need, expanding availability and changing how healthcare is delivered.

OXOS Medical is constantly innovating, building on our best-in-class imaging device, and expanding into cloud-based imaging platforms, robotic guided imaging, intraoperative computed tomography, and telemedical solutions. OXOS Medical has raised $70M from prominent MedTech investors, venture capital firms, and renowned orthopedic surgeons.

OXOS is searching for a Director of Regulatory Affairs and Quality Assurance to lead our regulatory & quality department; and is responsible for regulatory strategy, regulatory applications (510k, CE, CA, etc.), and ensuring MDSAP/ISO 13845 compliance (US, EU, Canada, Australia, etc.). The position is hands-on, leading a team of regulatory and quality support staff and technical support personnel. This position requires a technical background and will coordinate engineering & regulatory processes by directly interfacing with technical team leads and 3rd party auditors.

Responsibilities

• Create and drive the regulatory strategy for new and potential products by creating detailed plans and streamlined internal regulatory processes, to evaluate country-specific regulations, industry guidance, and testing requirements.
• Coordinate with engineering, R&D, executive management, QA, Sales, Marketing, and Operations, to gather all necessary information and data for regulatory filings.
• Develop and prepare regulatory submissions and responses for the US, Canada, EU and select worldwide locations (to include 510k, Letter to File, Technical Files, pre-submission meeting requests, etc.).  This role is expected to perform the majority, if not all of the submission and response writing.
• Identify potential regulatory risks based on regulation changes, industry-specific guidelines, or other project characteristics. 
• Review and approve advertising, promotional items and labeling for regulatory compliance.
• Design, implement, and continually refine OXOS’ quality management system.
• Execute annual MDSAP audits and meet all relevant requirements of the regulatory authorities.
• Hire, train and mentor resources and identify and implement support tools to scale OXOS’ internal quality team to meet Quality Management System Requirements.
• Conduct regular audits and assessments to identify and address any compliance gaps.
• Ensure that all necessary certifications and approvals are obtained on time.
• Manage all Adverse Event Reporting and prepare supporting strategies to remediate.
• Establish stringent supplier qualification criteria and regularly evaluate to ensure high-quality components and materials.
• Develop a design control process that ensures compliance while supporting OXOS’ need for development speed and flexibility.
• Facilitate QMS and Design Control Training across the entire OXOS organization.
• Oversee and ensure all design control testing, such as Verification & Validation testing, is executed effectively
• Hire, train, mentor and coach QA/RA personnel to support Design Control Requirements throughout the organization.
• Coordinate with 3rd party testing laboratories for proposals, protocol development, and test execution, as well as 3rd party GMP auditors for proposals and audit planning.

Required Qualifications

• 4-7 years (or more) of Regulatory experience in an FDA-regulated medical device industry, and working knowledge of MDSAP, ISO 13485, ISO 14971, and IEC 60601 standards. 
• Experience with clearing devices across international markets.  Experience with AI/ML, SaMD, SiMD, and cloud-based software products is a plus.
• In-depth knowledge of New Product Development process and Design Control requirements. Background in engineering discipline with deep familiarity with product design is preferred.
• In-depth knowledge of QC/QA activities and regulatory requirements in the medical device industry, preferably medical electrical equipment.
• Continuing education in the regulations, interpretation of the regulations, and revising internal practices and procedures to comply with the regulatory requirements.
• Lean Six Sigma certification or ASQ-Certified Quality Engineer (CQE) is a plus.
• Ability to excel in an ever-changing, fast-paced environm