About This Role   

As Lead, Emerging Technology Regulatory Affairs & Quality Assurance for ATDS, you’ll be responsible for end to end regulatory and quality strategy regarding integration of digital health and emerging technology assets into clinical trials. You will be the owner for SaMD related processes ensuring that quality strategy and documentation complies with FDA, ISO 13485 and international medical device regulatory standards.  You will also drive strategic and operational collaboration with Biogen regulatory & quality teams as appropriate. 

You will be accountable for maintaining, assessing, and documenting quality and regulatory status of digital health and other emerging technologies as used by Biogen in clinical trials. You will facilitate integration of digital health and other emerging technologies into clinical trials both directly and indirectly through quality management and product release processes.   

As these technologies are integrated across Biogen processes, you will be expected to tackle a variety of tasks to ensure RAQA for products but also monitor industry and regulatory trends to develop a strategy and provide guidance related to these trends in relation to other regulatory departments within Biogen, notified body and regulators. 

What You’ll Do  

• Manage and maintain digital health and emerging technologies in appropriate quality management systems 
• Serve as the QMS representative role as appropriate 
• Manage and maintain compliance with MDR, including CE Mark applications via Technical Files
• Manage and maintain compliance to ISO13485 requirements within Biogen for assets deployed in support of clinical trials 
• Serve as accountable party for responding and reporting incidence reports across markets, overseeing Customer Complaint Systems, and managing corrective actions for product failures 
• Monitor industry and regulatory trends to develop a digital and emerging technology regulatory strategy and provide guidance related to these trends 

Who You Are 

You are passionate about enabling appropriate integration of technologies and clinical research. You love balancing needs to find new paths with understanding of research stewardship, patient burden, and technology risk. 

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. 

Required Skills  

• Minimum 6-10 years Regulatory Affairs and Quality Assurance Management in software integration with the healthcare and life sciences industries
• Expertise in SaMD (incl. Smartphone App) 
• Significant experience in certification of a medical device 
• Significant experience with Privacy Policy regulation in a global environment (US, EU+ or APAC)
• Successful track record in medical devices (510K, CE marking) 
• Extensive network in the medical industry to identify industry trends and insights  
• Ability to prioritize tasks in a fast-paced environment 

The base compensation range for this role is $147,700 to $221,600. 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, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.