Regulatory Affairs Specialist I

Regulatory Affairs Specialist I to collect information and documentation for routine submissions to regulatory agencies, communicate with internal stakeholders, and maintain regulatory files.

Requirements

• Ability to multi-task in a fast-paced environment
• Working knowledge of principle compliance focused ISO Standards
• Proficient computer skills, including Adobe Professional and MS Office applications
• Bachelor's Degree in Scientific/Engineering discipline or equivalent work experience
• Understands the requirements of FDA 21CFR Part 820 QMSR, EU MDR, MDSAP, CMDR and ISO 13485
• Ability to represent Regulatory Affairs to other departments

Benefits

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement