About This Role:As the Director of Risk Management and Complaints within the Device Quality team, you will play a pivotal role in developing and maintaining risk management files for Class III drug delivery medical devices, ensuring compliance with standards such as ISO 14971. This position is responsible for crafting and updating strategies based on new therapeutic agents, supporting risk-driven premarket testing and global regulatory strategies. Your leadership will be key in developing procedures and technologies to adhere to post-market global reporting requirements. This role brings immense value by ensuring the safety and efficacy of our medical devices, fitting seamlessly into the overall business structure by collaborating with various departments to uphold quality and compliance.
This is a remote-based role with occasional travel required to our Headquarters in Cambridge, MA.
What You'll Do:- 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.
Who You Are: You are a strategic thinker with a deep understanding of risk management in the medical device industry. Your attention to detail and commitment to compliance guide your leadership, enabling you to navigate complex regulatory landscapes. You're adept at fostering collaboration across different teams, ensuring seamless processes and effective communication. Your ability to lead with integrity and inspire innovation makes you an asset to any organization.
Required Skills:- 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.
Job Level: Management
Additional InformationThe base compensation range for this role is: $178,000.00-$245,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
