Director, Risk Management, Complaints

🕒 2 days ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $178k - $245k / year

⏰ Full Time

🔴 Lead

🎲 Risk

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Biogen

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Biogen is a biotechnology company dedicated to discovering, developing, and delivering innovative therapies for people living with serious neurological diseases, including Alzheimer's disease, multiple sclerosis, and spinal muscular atrophy. With a strong emphasis on research and development, Biogen continues to advance the science of neurology through clinical trials and strategic partnerships, while also striving for access and health equity in healthcare.

📋 Description

• Lead the global strategy, governance, and execution of risk management, complaint handling, vigilance, and post-market surveillance activities for Class III implantable medical devices. • Develop and execute a strategic roadmap to modernize post-market surveillance and complaint management systems. • Own and continuously improve processes and quality system elements to ensure compliance with regulatory requirements. • Establish and oversee complaint intake, triage, investigation, documentation, trending, and closure processes. • Direct complex product complaint investigations and partner with engineering, manufacturing, suppliers, and clinical/medical stakeholders. • Lead post-market signal detection, trending, and quality data analytics using various field performance data. • Oversee risk management activities across the marketed product lifecycle, including hazard analysis and risk control effectiveness verification.

🎯 Requirements

• Bachelor’s degree; advanced degree preferred. • At least 12 years of experience in medical device quality systems risk management activities with at least 3 years of experience with Class III implantable medical devices. • Experience with FDA Quality Management System Regulation and EU MDR requirements. • Strong analytical skills and proficiency in quality data analytics.

🏖️ Benefits

• Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation