Senior Regulatory Specialist

Cypress HCM; Minneapolis (MN); On-site; USD 80,000 - 120,000; Full time

Job summary

A medical equipment company is seeking a Mid-Senior level Quality Assurance professional to assist with regulatory documentation and medical writing. The role involves reviewing engineering test reports, monitoring regulatory requirements, and ensuring compliance with FDA regulations. Ideal candidates will have at least 3 years of experience, strong writing skills, and proficiency in Microsoft Office Suite. This full-time position offers a competitive salary ranging from $80,000 to $120,000 annually, based in Minneapolis, Minnesota.

Qualifications

• Minimum of 3 years of scientific and/or regulatory experience.
• Strong experience writing and reviewing regulatory documentation.
• Excellent communication skills required.

Responsibilities

• Review engineering test reports and regulatory submissions.
• Approve documentation change requests.
• Monitor domestic and international medical device regulations.
• Ensure compliance with FDA submissions.

Skills

Scientific and regulatory experience

Technical documentation writing

Excellent verbal communication

Organizational skills

Attention to detail

Tools

Microsoft Office Suite

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