About this opportunity
Cypress HCM lists this Senior Regulatory Specialist opportunity in minneapolis, Minnesota. Review the employer’s description below for duties, qualifications and application requirements.
Job description
This range is provided by Cypress HCM. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$80,000.00/yr - $120,000.00/yr
Under general supervision, the individual in this role assists with medical writing and regulatory documentation, including preparation and finalization of test reports, regulatory filings, and review of marketing materials.
Responsibilities
Review and finalize engineering test reports and other documentation required for regulatory submissions.
Review and approve documentation change requests.
Monitor and analyze domestic and international medical device regulations to ensure submission requirements remain current.
Review product and manufacturing changes for compliance with applicable regulations.
Communicate new or updated regulatory requirements to relevant personnel.
Review device labeling and marketing materials to ensure compliance with FDA submissions and applicable regulations.
Perform other related duties as assigned.
Qualifications
Minimum of 3 years of scientific and/or regulatory experience.
Strong experience writing, reviewing, editing, and submitting technical and regulatory documentation.
Excellent verbal communication skills and ability to collaborate across multiple levels.
Preferred experience with IDE, PMA, 510(k), CTN, and Shonin submissions.
Advanced proficiency in Microsoft Office Suite (for publishing submissions).
Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
Ability to work independently while following direction as needed.
High attention to detail and accuracy.
Pay Rate:
$80-120k
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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Worksite address
minneapolis, MN, 55400, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.