Director, Risk Management and Complaints

Biogen, Inc.

Job Overview

Location

Remote, USA

Job Type

Full-time

Full Job Description

📋 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.
• Ensure compliance with ISO 14971, FDA Quality Management System Regulation, and EU MDR requirements in all risk and complaint management activities.
• Collaborate cross-functionally to align risk management strategies with premarket testing and global regulatory strategies.
• Support the development of procedures and technologies to meet post-market global reporting requirements.
• Apply strong analytical skills to interpret quality data and drive evidence-based decisions in risk and complaint resolution.
• Maintain up-to-date knowledge of evolving global regulatory landscapes and integrate changes into company-wide processes.
• Foster a culture of compliance, integrity, and innovation within the Device Quality team and across departments.
• Contribute to the overall business structure by ensuring the safety and efficacy of medical devices through rigorous risk and complaint management practices.
• Participate in occasional travel to the company headquarters in Cambridge, MA.

🎯 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
• Demonstrated leadership in developing and executing risk management and complaint handling strategies
• Proven ability to direct complex product investigations and collaborate with engineering, manufacturing, and clinical stakeholders

🏖️ 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
• Eligibility for short-term and long-term incentives including cash bonus and equity incentive opportunities

Skills & Technologies

Remote

Degree Required

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Biogen, Inc.

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About Biogen, Inc.

Biogen is an American biotechnology company that develops and manufactures therapies for neurological and neurodegenerative diseases. Founded in 1978, the company focuses on treatments for conditions such as multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, and amyotrophic lateral sclerosis (ALS). It also produces biosimilar drugs for immune and inflammatory diseases. Biogen operates globally with research, development, and manufacturing facilities supporting its mission to improve outcomes for patients with serious neurological disorders.

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