Base: $110,200 to $138,000 py; bonus/equity: incen...
Hybrid
510(k) submissions for us class ii devices
Eu mdd and eu mdr technical documentation
Qsr 21 cfr 820 and iso 13485 compliance
The role involves developing regulatory strategies and preparing U.S. regulatory submissions to obtain and maintain approval for products worldwide
Job Summary
The role involves developing regulatory strategies and preparing U.S. regulatory submissions to obtain and maintain approval for products worldwide.
Candidates must possess extensive experience with 510(k) submissions, EU MDD/MDR technical files, and ensuring adherence to QSR and ISO standards.
The position offers a comprehensive benefits package including health insurance, 401(k) matching, and paid time off for regular employees working 20+ hours per week.
Matching Summary
The role involves developing regulatory strategies and preparing U.S. regulatory submissions to obtain and maintain approval for products worldwide.
Salary
Base: $110,200 to $138,000 per year; Bonus/Equity: Incentive plans available; Benefits: Health, dental, vision, 401(k) match, PTO
Skills & Requirements
Must-have
510(k) submissions for US Class II devices
EU MDD and EU MDR technical documentation
QSR 21 CFR 820 and ISO 13485 compliance
Clinical Evaluation Reports and Risk Management review
ISO 10993-1 biocompatibility and IEC standards support
Nice-to-have
Total product life-cycle regulatory activities experience
Post-market clinical follow-up expertise
Hybrid work model adaptability
Global regulatory requirements beyond US and EU
Key Requirements
Master's degree in Regulatory Affairs or related field
Bachelor's degree plus five years of relevant experience
Minimum three years experience with 510(k) submissions
Three years experience with EU MDD/MDR technical files
Experience with DHF reviews and Clinical Evaluation Reports