ABOUT US

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Our mission is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Learn More

KNOWLEDGE, SKILL & ABILITIES:

• 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)

EDUCATION & EXPERIENCE:

• 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.

PREFERRED QUALIFICATIONS:

• Familiarity with AI-based software, medical imaging, active devices.

ABOUT THE ROLE

Job Title: Regulatory Affairs Associate
Location: Guilford, CT
As our Regulatory Affairs Associate, you will be an individual contributor responsible for analysis, evaluation, preparation, and submission of documentation for regulatory approval, ensuring Hyperfine products and procedures comply with US and global regulatory specifications. You will support our Regulatory team across different program areas, and will work on multiple projects concurrently.

KEY 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.