Regulatory Affairs Associate

Job Description

Job Description

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

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.

Knowledge, Skill & Abilities :

Education & Experience :

Preferred Qualifications :

Physical Demands :

Compensation : The annual base salary for this position is between $77,000 - $88,500 . This position is also eligible to participate in Hyperfine's corporate bonus and equity plans. Individual compensation packages are based on various factors unique to each candidate including skill set, relevant experience, qualifications, location, position level, and other job-related reasons.

Work Authorization : Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.

Agency Resumes : Hyperfine is not accepting resumes from recruitment agencies. Any unsolicited resumes submitted by agencies will be considered the property of Hyperfine and will not be subject to any fees or charges if the candidate is hired.