Clinical & Regulatory Affairs Manager - AQMed

About the Role

We are seeking a highly motivated and experienced Clinical & Regulatory Affairs Manager to join our AQMed team. You will play a central role in preparing for and initiating the multi-site US pivotal study, playing a key role in bringing an innovative device to market.  You will also be playing a strategic and execution role in navigating the regulatory landscape for our groundbreaking medical device, CardiAQ™, and future products. This position involves developing regulatory strategies, preparing submissions, and ensuring compliance with global regulatory requirements to bring our innovative solutions to market.

What You'll Do

Clinical

• Lead US pivotal study launch, working alongside the company’s Head of Product and clinical operations consultants.
• Manage and optimize ongoing US feasibility studies to ensure strong partnerships with our leading clinical sites.
• Write clinical study protocols and clinical study reports, emphasizing bringing key evidence to leading publications in close collaboration with our clinical partners.  
• Manage clinical research activities, including site selection & qualification, preparation of study-related documents & records (e.g. investigator’s brochure, CRF/EDC design), IRB submission and reporting, with support from consultants and/or CRO.
• Expand and cultivate our relationships with international clinical partners.

Regulatory

• Formulate, communicate, and implement regulatory strategies for the CardiAQ™ device throughout its product lifecycle, both US and OUS
• Lead US FDA regulatory submissions (e.g. pre-submission, BDD, IDE, 510(k), De-Novo as appropriate) and negotiation in conjunction with our regulatory consultants.
• Collaborate with R&D, Quality, and Manufacturing to ensure the development, testing, and release processes of our product align with industry requirements and standards (e.g. ISO) 
• Review and approve labeling, advertising, and promotional materials for compliance purposes.
• Compile and submit regulatory filings to international regulatory bodies.

About You

• You have a bachelor's degree in biomedical engineering, life sciences, or a related field; an advanced degree is preferred.
• Minimum of 10 years of industry experience in medical devices, serving in clinical and/or regulatory affairs, with significant leadership responsibility.
• Experience preparing regulatory submissions for the FDA, including successful approvals of 510(k) and/or de-novo. 
• Experience launching and managing multi-center pivotal studies; international site management experience is a plus.
• Cool Under Pressure: You remain composed in challenging situations and act as a lighthouse amidst technical complexities.
• Team Player & Builder: You contribute to a win-as-a-team culture and foster collaboration across different engineering disciplines.
• Desire to Move Fast: You challenge the status quo and aim to deliver results faster than traditional timelines.
• Detail-Oriented: You pay close attention to details and hold yourself and others accountable.
• Passionate About Solving Unmet Medical Needs: You are deeply motivated to improve patient outcomes through innovation.
• Deeply Curious: You have an insatiable desire to learn and explore new ideas.
• Thoughtful About Risk: You carefully assess risks and make informed, steadfast decisions.

Preferred Qualifications

• Experience with Class II and Class III cardiovascular diagnostics and imaging devices is strongly preferred. 
• In-depth knowledge of FDA regulations, ISO 14155, ISO 13485, MDR, and other global regulatory requirements.
• Strong understanding of clinical trial regulations and Good Clinical Practice (GCP).

The US base salary range for this full-time position is expected to be $183k-257k per year. Our salary ranges are determined by role and level. Within the range, individual pay is determined by factors including job-related skills, experience, and relevant education or training. This role may be eligible for annual discretionary bonuses and equity.