Senior 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. 

A Day in the Life / Responsibilities

• Work with RA/QA, tech team, and other relevant stakeholders to resolve potential regulatory issues and questions from regulatory agencies.
• Prepare FDA submissions and CE Mark Technical Files for new products and/or product changes as required to ensure timely approvals for market released products.
• Provide support to currently-marketed products as necessary. This includes reviewing product changes and documentation for changes requiring government approval. 
• Manages submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, Q-subs, IDEs, and establishment registrations and device listings.
• Interact directly with FDA and indirectly with international regulatory agencies on most projects/products. 
• Maintain proficiency in US/EU regulatory requirements; establish and maintain good relationships with agency personnel.
• Follow all work/quality procedures to ensure quality system compliance and high-quality work.

Must Have: Minimum Requirements

• Minimum 5 years of regulatory experience in medical device, biotech, or pharmaceutical industry with Bachelor’s degree.
• Minimum 2 years of regulatory experience in medical device, biotech, or pharmaceutical industry with an advanced degree.
• Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for medical devices (PMA, 510(k)), Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III)
• Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
• Ability to compile data and summarize results
• Organized, efficient, process-oriented; high attention to detail
• Effective interpersonal/communication skills
• Works well under pressure in a dynamic timeline-driven environment
• Ability to effectively manage multiple projects and priorities
• Experience with Google Docs, Word, Adobe

Nice To Have:

• AI/ML SaMD experience
• History of successful 510(k)/IDE/PMA and EU MDR technical file device submissions submissions and clearances. 
• Experience with regulatory support of clinical trials

Salary: $100,000 - $125,000

Why you should apply:

• PURPOSE: Cleerly’s purpose is to create a world without heart attacks. With our new paradigm for precision heart care, we will leave big footprints in the sands of time. Help us make that a reality!
• COMMUNITY: We are building a truly world class team of talented problem solvers. While we have diverse backgrounds, we are united in our commitment to each other, to our customers, and to the patients our technology serves.
• GROWTH: We prioritize learning and growth. As a rapid growth company, there is always space for new challenges and responsibilities.
• OWNERSHIP: Everyone on the team contributes to our success, so everyone has equity in the company through our employee stock option incentive plan.
• BENEFITS: Cleerly offers a variety of medical, dental, and vision plans, designed to fit you and your family’s needs. Along with stock options and a 401(k) match program that helps you invest in the future, Cleerly also offers 7 company wide holidays, a week off between Christmas and New Years as well as a self-managed PTO policy.
• We are committed to a positive organizational culture and a continuous