Sr. Regulatory Affairs Specialist

About Cleerly

We’re Cleerly – a healthcare company based in Denver, Colorado and New York, New York that’s revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world’s leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which will enable rapid growth and continued support of our mission. 

Cleerly is creating a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly’s solutions are supported by more than a decade of performing some of the world’s largest clinical trials to identify important findings beyond symptoms that increase a person’s risk of heart attacks. 

About the Opportunity

We are a growing startup company focused on developing and distributing machine learning (artificial intelligence) solutions for medical applications. The Senior Regulatory Specialist must be a key expert in regulatory and quality affairs both domestic and internally. This position requires that candidate be able to work independently and be a self-starter with limited resources available. The Senior Regulatory Specialist will be responsible for owning the regulatory and quality activities within the company. You will also be responsible for staying abreast of all regulatory changes and set the company up for success.

You'll be joining a team that delivers at high frequency by using and creating the latest technologies, interacting constantly with your team and communicating daily with the product team. You will also be working daily with data scientists and medical doctors, who will help to integrate software solutions with the healthcare diagnosis systems, all in an environment conducive to productivity, brainstorming, and close collaboration across teams, with each team member being an integral part of the creative process.

Responsibilities

• Assists with activities related to domestic and regulatory submission and approval for medical software solutions.
• Work with senior leadership, cross functional teams and external consultants on regulatory strategy for domestic and international markets assuring early consideration of regulatory requirements.
• Prepare and coordinate domestic regulatory submission filings for Class 2 devices.  Draft and file traditional and/or special 510k, De Novoas well as pre-submissions (Q-subs), IDE requests and reports, and post-market reports.
• Support the product development team in the implementation of regulatory requirements, including preparation and review of design and test documentation, assessment of product changes, and interpretation of guidance and standards.
• Provide regulatory review/approval for promotional materials, press releases, and corporate presentations for compliance to label claims, FDA, FTC and any applicable foreign regulation. 
• Maintain the company's medical device listing and device and establishment registrations. Compile materials for license renewals, updates, and registrations.
• Oversee Import/Export regulatory requirements for country-specific jurisdictions.
• Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products. Advise the company on any changes to Regulations or Standards that would affect our regulatory strategy or business objectives.
• Maintain regulatory files in good order, establishing and maintaining a system for tracking changes in documents submitted to agencies.
• Review and approve all design control documentation, engineering change requests for design, manufacturing, labeling changes, product releases and customer requests to ensure compliance with FDA and international government regulations.
• Support internal and external audits.
• Comply with company policies and guidelines.

Requirements 

• Bachelor’s degree
• 3-5 years of Regulatory experience with Class II or III medical devices.
• In depth knowledge 21 CFR 820, IEC 62304, ISO 62366-1, ISO 13485, and ISO 14971.
• History of successful 510(k), IDE, and/or PMA device submissions. Other worldwide submissions and clearances are a plus. 
• Experience with new product development projects for software as a medical device (SaMD) or medical device component. Ability to review and provide critical feedback on design documentation.
• Excellent command of the English language; ability to draft and revise docu