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ISO 13485, EU

IVDR, Health Canada SOR 98/282 and 21 CFR 820 Develop technical documentation and quality records Facilitate risk management including FMEA and Hazard Analysis Assist with regulatory and quality requirements Improve Chrono-log's Quality Management system and regulatory capability What You Bring Degree in Engineering, Biomedical Engineering, Industrial Design, Science, or similar 5+ years in medical device development or manufacturing 4+ years in Regulatory Affairs within medtech Experience preparing regulatory submissions and supporting approvals Strong understanding of

ISO 13485, EU IVDR, 21 CFR 820

Experience with FMEA, Hazard Analysis, and risk management RAC, FRA, or equivalent credential (desirable) Collaborative, motivated and organized Benefits Employer Funded Retirement Plan Health Insurance Vision Insurance Dental Insurance Health Savings Account (HSA)

Paid Time Off Life Insurance Pay:

$65,000.00 - $100,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Retirement plan Vision insurance

Education:

Bachelor's (Preferred)

Experience:

Regulatory Affairs:

4 years (Required)

License/Certification:

RAC, FRA, or equivalent credential (Preferred)

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Find & Apply For Regulatory Affairs Specialist Jobs in Havertown, Pennsylvania

Regulatory Affairs Specialist