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Regulatory Compliance Specialist III
1 week ago
Verathon is a global medical device company dedicated to delivering high-quality products that support customers in their daily work. The company has significantly impacted patient care by developing innovative solutions for bladder volume measurement and airway management.
Salary RangeThe salary range for this position is between $76,423 and $104,949. Compensation will vary based on skills, experience, and location.
Job ResponsibilitiesThis role requires defining and maintaining compliance engineering requirements for product design and testing. Key responsibilities include managing and maintaining worldwide standards databases, leading cross-functional teams, and liaising with external test houses and notified bodies.
- Define and provide compliance engineering requirements for product designs, updates, and testing.
- Manage and maintain Verathon's worldwide standards database.
- Liaise with external test houses (UL, CSA, Intertek etc.) and with notified bodies on compliance topics.
A Bachelor's Degree in a Scientific or Engineering field is required. A minimum of 5 years' experience in compliance and/or quality system activities in a QSR/ISO 13485 Quality Management System and MDSAP audits is necessary. Knowledge of regulatory requirements such as GMPs, MDD/MDR, CMDR, TGA, ANVISA, PMDA, and international product safety standards is essential.
BenefitsFull-time employees are eligible for Verathon's annual bonus plan based on company and individual performance. A competitive benefits package includes a generous Health Care Spending Account, paid holidays, paid time off, and a retirement matching plan.
