Head of Global Regulatory Affairs & Quality

Responsibilities:

• Provide strategic leadership to develop and implement regulatory strategies throughout the product lifecycle aligned to company goals and objectives. 
• Preparation of amendments/supplements, new device applications, 510(k)s, technical documentation (EU MDR), and design dossiers
• Lead internal audit activities for MDSAP, EU MDR, and ISO 13485 compliance.
• Maintain and scale QMS and develop pathways for closing gaps and maintaining compliance.
• Lead regulatory efforts required to align with new regulations and requirements including changes to international standards.
• Interpret Regulatory Authority policies and guidance and integrate them as appropriate in product development, quality, and  regulatory activities.
• Provide strategic direction to the quality engineering team with a focus on design assurance and post-market surveillance.
• Lead and scale international product registrations (3-4 countries per year)
• Provide strategic clinical and regulatory input and guidance to cross-functional teams across the organization, including R&D, manufacturing, marketing, and quality assurance

Qualifications:

• Degree in Engineering, Life Sciences, or related fields; Advance degree preferred.
• 10+ years of experience in regulatory affairs in the medical device industry; prior 510(k) submission and EU MDR experience required. Experience with medical devices that include complex software and hardware systems is desirable.
• Proven success building and maintaining quality management system.
• Excellent grasp of all pertinent regulations for medical device design, development, pre-clinical and clinical trials, and commercialization.
• Strong ability to work cross-functionally to advocate for and serve as the voice of regulatory and quality throughout the product life-cycle
• Experience communicating directly with FDA and notified bodies in association with new product submissions and external auditing.
• Positive, energizing, and hands-on leader, with the ability to collaborate in a dynamic start-up environment