Medical Device Complaints Manager

SharkNinja is seeking a Medical Device Complaints Manager to lead the design, execution, and continuous improvement of the company's global medical device complaints and post-market surveillance processes. The role is accountable for ensuring complaints are consistently captured, investigated, and escalated in compliance with global regulatory requirements.

Requirements

• Bachelor's or Master's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline
• 7–10+ years of experience in medical device complaints handling, post-market surveillance, vigilance, or quality systems
• Strong hands-on experience with complaint investigations, adverse event reporting, vigilance submissions, trending, and CAPA integration
• Proven experience designing, operating, and scaling medical device complaints and post-market processes compliant with 21 CFR Part 820 / FDA QMSR, ISO 13485, and EU MDR

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Health savings accounts (HSA) with company contribution
• 401(k) retirement plan with matching
• Employee stock purchase program
• Life insurance
• AD&D
• Short-term disability insurance
• Long-term disability insurance
• Generous paid time off
• Company holidays
• Parental leave
• Identity theft protection
• Pet insurance
• Pre-paid legal insurance
• Back-up child and eldercare days
• Product discounts
• Referral bonus program