Principal Regulatory Affairs (or Director)
Boston, MA /
Regulatory Affairs & Quality Assurance /
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 have an innovative, result-orientated work environment where we foster ambition and dedication while being mindful of our teammates’ work and achievements. We also nurture our company culture with monthly all-hands meetings and apéros, weekly yoga classes, and other fun activities.
As we continue to grow, we are looking for a Principal Regulatory Affairs to join the team in Boston.
What you will do
We are looking for a Principal Regulatory Affairs to help with the US FDA and global regulatory efforts.
- Liaise, negotiate, and orchestrate meetings and communications with external regulators in the US and Globally
- Help VP of regulatory to formulate regulatory strategy and tactics for all regulatory submissions in US and Globally
- Manage relationships with internal and external stakeholders
- Participate in company team meetings and help shape regulatory strategy
- Provide regulatory support and guidance and manage day-to-day regulatory activities
- Review and interpret regulatory guidelines and keep up to date with US and EU regulations
- Help with internal and external audits (CE, FDA, MDSAP, global audits)
- Maintain US and Global regulatory knowledge in an organized matter
- Assist/lead global regulatory submissions (APAC/ALAC other regions)
- Assist in gathering requirements and documentation and help build regulatory guidance and strategy
- Help train the organization about global regulatory requirements
- Assist/lead creation of technical files and global internal and external submission documents
- Assist with regulatory project plans and timelines and ensure all projects are appropriately prioritized and key goals are met on time
- Work with internal and external partners on planning and execution of projects and help with timely communication with external partners and present the company in meetings
- Assist/Oversee compilation, electronic processing, and publishing to ensure high quality and timely electronic submissions compliant with regulatory authority requirements
- Oversee the maintenance and creation of relevant SOPs, Work Instructions, and other necessary guidance
- Lead maintenance of the change management process internally and change management notifications and amendment submissions globally
- Assist with EU MDR and CE marking and surveillance audits
- Assist/lead EU MDR, implementation and maintenance of EU MDR and maintain CE marking.
Who you are
- You have at least 5 years of experience in document control and eQMS 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