Regulatory Program Manager

Boston, MA /
Regulatory Affairs & Quality Assurance /
Full-time
At Cardiologs, our mission is to make tomorrow’s medical diagnosis efficient and accessible to everyone, anywhere, anytime. We leverage machine learning (AI) and cloud computing technologies to fulfill this vision. Our Cardiologs platform is leading software for the analysis of ambulatory ECG used to help diagnose +500,000 patients every year. More recently, we launched a Remote Patient Monitoring solution in the US to help physicians streamline ECG reviews.   

We are a small Boston-based team conveniently located off of the Charles/MGH Red Line station. We nurture our company culture with biweekly all-hands meetings and various office events that include lunch, dinner, and drinks. Most importantly, we believe that a good atmosphere at work makes people more efficient in what they are best at, so we hope you'll bring your own energy to our office.

As we continue to grow, we are looking for a Regulatory Program Manager to join the team in Boston.

What you will do

We are looking for a Regulatory Program Manager to lead Cardiologs QMS activities.

You will:

- Work closely with Corporate Regulatory Affairs and Quality Assurance to identify new regulatory requirements.
- Review and interpret new regulatory requirements and develop implementation plans.
- Lead and report on Regulatory activities related to the implementation of new regulatory requirements.
- Coordinate and manage regulatory timelines for projects/products shared across different business units.
- Manage regulatory deliverables and cross-functional deliverables from clinical and engineering teams.
- Participate in reviews of new and/or revised guidance, regulations, and standards applicable to the business unit. 
- Train business on new/revised guidance, regulations, and standards.
- Manage and lead special regulatory-focused projects and process improvements across the business.
- Provide Regulatory Affairs support for new product development, sustaining, and advanced development efforts in both the domestic and international markets for assigned business units.
- Provide direct project support for registration and licensing in mature markets and indirect support to the emerging markets group for all other licensing, as deemed necessary.
- Lead and manage international registration projects for complex countries (ex. Japan, Brazil, China) and be the interface between business marketing / regulatory and in-country marketing / regulatory
- Manage and maintain regulatory information in an organized way. 

Who you are

- You have at least 5 years of experience in QMS activities
- You excel in time management and paying attention to details
- You have excellent organization and people management skills
- You write and speak English - you'll work in an international distributed team

What we value

We value a positive mindset, collaboration, sense of ownership, transparency, the ability to embrace ambiguity, a talk-less-do-more attitude, and a sense of humor to enjoy ourselves along the way. If you identify with our values and want to contribute to our company, we’d love to have you in!

What we offer

- Beautifully by-the-book startup offices in Boston
- A respectful, fun, collaborative work environment
- Flexible WFO/WFH policy
- Yearly team off-sites
Our recruiting process
Being authorized to work in the US is a precondition of employment.

- Quick call with a RAQA team member and a quick introductory HR phone call
- Technical interview in our office or by Zoom
- Performance interview  in our office or by Zoom
- Culture interview (with lunch or drinks with the team if possible!)
- Quick call with our CEO, Yann (only if you did not have the opportunity to meet him in one of the previous interviews)
- Reference calls