Sr. Risk Manager- Medical Devices & Combination Products

Job Description

The Sr. Risk Manager – Medical Devices and Combination Products will be responsible for the execution of Risk Management activities for innovative medical devices and combination products, across various routes of administration such as subcutaneous and intramuscular injection, intravenous infusion, and intrathecal injection.

As an expert in Risk Management, the Sr. Risk Manager drives key activities throughout all development phases for clinical and commercial programs, facilitates the deliverables to support regulatory filings, product launches, and post-market surveillance requirements.

What You’ll Do

• Be an expert in medical device / combination product Risk Management.
• Author Risk Management deliverables for medical devices and combination products for multiple programs.
• Facilitate cross-functional discussions that include stakeholders in Risk Management deliverables such as External Partners, Device Design, Human Factors, Clinical Development, Safety, Quality, Regulatory CMC-Device, and Manufacturing.
• Review and approves relevant Design Control deliverables for multiple on-going projects.
• Author relevant sections of regulatory filings and respond to regulatory inquiries related to Risk Management.
• Liaise with department leadership and stakeholders to implement mitigations for identified risks.   

Qualifications

Required Skills

• Bachelor’s degree in engineering or related field.
• 8+ years’ experience in Development of Medical Devices and Risk Management related areas.
• Knowledge of the regulatory and compliance requirements of device design controls, Risk Management, human factors (i.e., ISO 14971, FDA QSR 21 CFR 820 / ISO13485 quality system requirements, ISO 62366 parts 1 and 2, and other relevant global standards).
• Experience authoring key Risk Management deliverables such as Plans, Hazard Analyses, FMEAs, and Risk-Benefit Analyses.  
• Experience developing medical devices and/or combination products from inception through registration and launch.
• Experience gathering and analyzing post-market surveillance data.

Preferred Skills

• Master’s Degree preferred.
• Experience with Risk Management of electro-mechanical devices and/or Software as Medical Device

Who You Are

You are an ambitious team member with exceptional interpersonal and communication skills, with an ability to communicate across multiple levels and disciplines within the organization. You enjoy working on a variety of challenging projects, in a fast-paced environment, while providing subject matter expertise in complex situations. You have a strong people focus with a creative and collaborative personality.

Additional Information

The base compensation range for this role is $94,200-$151,800. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religi