Senior Regulatory Specialist

Job overview

The Senior Regulatory Specialist role is onsite in Maple Grove, MN. Salary is $80,000–$120,000 per year, with a target bonus of 7%–10% of salary. The role supports global regulatory compliance for transcatheter heart valve technologies. The specialist prepares, reviews, and finalizes technical and regulatory documentation to support IDE, PMA, and international filings. By monitoring regulatory requirements and reviewing product changes, labeling, and marketing materials, the role helps keep products and processes compliant and supports timely submissions and approvals.

What you'll do

• Review and finalize engineering test reports and other submission documentation
• review and approve documentation change requests
• monitor and analyze domestic and international medical-device regulations
• review product and manufacturing changes for compliance
• distribute new or modified regulatory requirements to appropriate personnel
• review device labeling and marketing materials for compliance.

What we're looking for

Skills & competencies

senior regulatory specialist

maple grove mn

cypress hcm

full-time

$80k–$120k

target bonus 7%–10%

medical devices

regulatory compliance

regulatory submissions

test reports

ide

pma

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree and at least three years of scientific and/or regulatory experience. IDE, PMA, 510(k), CTN, and Shonin application experience is preferred.

About the employer

Cypress HCM is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.