Senior Regulatory Specialist

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