Hyperfine | AI-Powered Portable MRI · 5 months ago
Regulatory Affairs Associate
Guilford, Connecticut
Full-time
Hybrid
Entry Level
$77K/yr - $88K/yr
1+ years expHyperfine, Inc. is a groundbreaking health technology company that has redefined brain imaging with the Swoop® system. As a Regulatory Affairs Associate, you will be responsible for the analysis, evaluation, preparation, and submission of documentation for regulatory approval, ensuring compliance with US and global regulatory specifications.
Medical Device
No H1B
Responsibilities
Provide general support for regulatory strategies to optimize business expectations related to domestic and international commercial product availability
Assist in preparing regulatory applications that are compliant with applicable regulatory requirements to achieve business objectives
Assess the impact of global regulations, standards, and guidelines to the Hyperfine’s products and procedures
Assist with creating and updating regulatory procedures
Assist with regulatory agency responses, audits, and meetings
Review protocols, reports, and various change orders
Other duties as assigned
Qualification
Required
Bachelor's degree in a scientific or regulatory discipline, plus 1 year of experience in Regulatory Affairs or 2 years in the medical device industry; Master's degree with a minimum of 6 months of related experience; or equivalent combination of education/experience
Experience with US and International regulatory submissions
Detail-oriented, hands-on, proactive problem solver
Excellent written and oral communication skills
Comfortable reading, analyzing and interpreting technical documents, professional journals, technical procedures, and regulations
Ability to quickly adapt to new professional collaborative environments, deal with ambiguity, take initiative, and achieve results
Comfortable with scientific/medical data and nomenclature
Knowledge of regulatory clearances/approvals in global markets
Ability to work in a fast-paced environment with shifting priorities
A willingness to wear 'many hats' and eager to learn about emerging technologies and find creative solutions
Proficiency with Microsoft Office programs (e.g., Word, Outlook, and Excel)
Applicants must be authorized to work for any employer in the U.S
Preferred
Familiarity with AI-based software, medical imaging, active devices
Benefits
Eligible to participate in Hyperfine's corporate bonus and equity plans
Company
Hyperfine | AI-Powered Portable MRI
The Swoop® system brings MR brain imaging within reach.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Maria Sainz
President & CEO
Matthew Rosen
Co-Founder
Recent News
Medical Product Outsourcing
2025-09-05
Company data provided by crunchbase