Regulatory Affairs Associate
Regulatory Affairs Associate
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Salary Not Disclosed
1 Vacancy
Job Description
About Us
Hyperfine Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with theSwoopsystemthe 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 Hyperfines 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:
- Bachelors degree in a scientific or regulatory discipline plus 1 year of experience in Regulatory Affairs or 2 years in the medical device industry; Masters 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 Hyperfines 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 $77000 - $88500. This position is also eligible to participate in Hyperfines 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.
Required Experience:
IC
Employment Type
Full Time
