Sanofi Group Associate Director, Regulatory Affairs Medical Devices in Cambridge, Massachusetts
Sanofi’s global regulatory function is comprised of more than 1800 people. The Associate Director, Regulatory Affairs Medical Devices – Medical Device Software and Connected Devices will oversee key regulatory activities and report to the Director of Regulatory Affairs - Medical Device Software and Connected Devices, who in turn reports to the Head of Regulatory Affairs Medical Devices. The incumbent will be a valuable member of a global team of medical device Regulatory Affairs professionals, predominately based at sites in and around Cambridge, Massachusetts, and will work closely with key stakeholders implementing medical device and drug delivery device systems technologies.
The incumbent will be primarily focused on Sanofi’s digital health and connected devices portfolio but will also have the opportunity to work on other innovative projects. Medical device and drug delivery device systems technology is often exploring new territories that need “new” thinking and approaches from a regulatory perspective. The incumbent will be expected to proactively initiate discussions with regulatory authorities and contribute to industry standards and guidelines.
Serve as Regulatory Affairs – Medical Device Software and Connected Devices lead on assigned project teams
Develop innovative and sustainable medical device regulatory strategies covering medical device software and connected drug delivery systems (device elements)
Provide regulatory guidance and advice to development teams; Review and approve design control deliverables
Lead and/or support global filing activities for digital health and connected device products
Lead and/or support device related health authority interactions
Provide regulatory impact assessments for proposed product changes
Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed
Establish internal regulatory processes and procedures for medical device software and connected devices. Engage with the relevant regulatory bodies and industry groups to influence industry standards and regulations, ensuring that Sanofi’s best interests are represented.
This critical and highly visible position offers the successful candidate the opportunity to support a wide range of products, from software-based programs through to drug delivery devices, all of which are part of Sanofi’s exciting development pipeline.
This position requires proven international experience from within a global healthcare organization with a track record of involvement in medical device – drug combinations. The incumbent will have had experience working in large and complex organizations, given the need to be able to interact across the Sanofi organization. The ability to think outside the box and assure that Regulatory Affairs is seen as a knowledgeable partner is also a key expectation. In terms of technical expertise, the incumbent will have a solid understanding of regulatory requirements and technical/industry standards related to medical device software and drug delivery systems, such as auto-injectors, pre-filled syringes.
At least 10 years in the global healthcare industry with relevant experience (7+ years) in drug-device combinations and medical device software
In-depth understanding of and experience with global medical device regulatory approvals
Prior experience interacting with regulatory authorities
Proven ability to work cross-functionally in a highly professional global environment
Bachelor’s degree in life sciences or engineering with at least 5 years of relevant medical device regulatory or medical device / software medical device quality assurance experience or a combination of a Master’s degree relevant experience
Ability to synthesize and critically analyze data from multiple sources;
Dynamic personality, ability to think outside the box;
Demonstrates initiative and capacity to work under pressure;
Ability to influence;
Excellent teamwork and interpersonal skills;
Excellent communication skills, both written and verbal, in English;
Ability to travel internationally
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life