New

Regulatory Affairs Associate

Guilford, Connecticut

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:

  • 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.

Physical Demands:

  • This is a hybrid role based at Hyperfine's facility in Guilford, CT. 
  • Occasional availability during nights, weekends, and holidays as business needs require.
  • Ability to speak, write, and use all office equipment including scanner and printer, phone, computer, etc.

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.

Create a Job Alert

Interested in building your career at Hyperfine? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Hyperfine’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.