Quality Regulatory Manager - Field Actions

2 days ago

🇺🇸 United States – Remote

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $124.2k - $232.8k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Agilent Technologies

WebsiteLinkedInAll Job Openings

Diagnostics & Genomics • Chemical Analysis • Life Sciences • Environmental & Forensics • Food Safety

10,000+ employees

Founded 1999

🔬 Science

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2019-09

Description

• Ensures quality products align with regulations and customer expectations. • Develops programs for product safety and regulatory compliance. • Oversees quality activities and executes strategic programs. • Manages field action operations and communications with global Health Authorities.

Requirements

• Bachelor of Science degree in Engineering or Scientific/Technical discipline or other relevant education. • Master’s degree preferred or directly equivalent experience. • Minimum of 4 years relevant professional experience in the MD/IVD, Pharma, or other related Life Science industry. • Minimum of 2 - 4 years working with remedial actions, such as Field Actions, Field Safety Notices (FSN) or Field Safety Corrective Actions and other related post market surveillance activities. • Excellent professional writing skills in English. • Prior experience with and knowledge of FDA, EU MDR, and Canada, and other global regulations.

Benefits

• Bonus eligibility • Stock options • Health benefits • Equal Employment Opportunity • Affirmative Action employer