We are seeking a detail-oriented Quality Management Systems (QMS) specialist with experience in EU MDR and FDA medical device regulations. Key responsibilities include:

• Lead and coordinate the certification process for achieving FDA QSR/QMSR and ISO 13485 compliance, with responsibility for implementing and maintaining our Greenlight Guru / Ultralight Quality Management System (QMS).
• Lead and coordinate the certification process for Software as a Medical Device (SaMD) in compliance with EU Medical Device Regulation (MDR) and US FDA.

Quality Management System

• Overall responsibility for achieving FDA QSR/QMSR and ISO 13485 certification for our company
• Manage our Greenlight Guru / Ultralight Quality Management System (QMS), including ongoing collection and storage of evidence required to maintain our certification
• Develop and enforce tailored procedures in accordance with our QMS policies and Standard Operating Procedures
• Support internal and external quality management audits.
• Conduct gap analyses and implement corrective actions to address compliance issues.
• Analyze quality metrics and trends to identify opportunities for system improvements.
• Participate in software design reviews and verification/validation activities as the quality system representative.
• Support software life cycle processes adherence with IEC 62304 and other applicable standards.

Regulatory Compliance

• Prepare for regulatory compliance with the EU Medical Device Regulation (MDR), to gain approval for our SaMD platform for use in neurology clinics throughout the EU, as well as for use as a certified clinical end point for drug trials,
• Prepare regulatory submissions to the US FDA for use as a certified clinical end point for drug trials, as well as building on our Class II Software as a Medical Device designation for deployment in neurology clinics.
• Working closely with our team of Human Kinetics PhDs, prepare and submit all required technical documentation, including design dossiers, risk management files, clinical evaluation reports and testing data.
• Serve as the primary liaison with regulatory authorities, respond to queries, and facilitate audits and inspections.
• Support post-market surveillance and reporting requirements to maintain compliance.

Education & Experience

• College diploma or bachelor’s degree in Life Sciences, Quality Assurance, Regulatory Affairs or related field.
• 5+ years’ experience in quality management and regulatory affairs, specifically related to SaMD; includes experience managing and maintaining a Quality Management System
• In-depth knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304, FDA QSR (21 CFR Part 820), ISO 13485:2016 and other relevant standards.
• Proven experience in successful regulatory submissions and obtaining approvals for SaMD products.
• Excellent oral and written communication, project management, and problem-solving skills.
• Certification in Regulatory Affairs (RAC) or equivalent preferred.
• Ability to work independently and collaboratively in cross-functional teams.
• Strong analytical and problem-solving skills.

We Offer:

• Competitive salary and benefits package
• Opportunity to work at the forefront of medical technology, in collaboration with our team of Human Kinetics PhDs, senior neurologists and patient advisors
• Dynamic and collaborative work environment
• Professional growth and development opportunities