Sanofi Group Senior Manager Medical Device Software Factory in Cambridge, Massachusetts

Our mission is to support the Sanofi business units by delivering differentiated services and solutions that help patients, physicians, care takers, payers as well as Sanofi to better take care of patients and provide an improved outcome to the healthcare system. Our services and solutions sit on top of our market leading technology platform which we continue to evolve. We have recruited top talent in the field of Digital Health to help transform care in Diabetes and beyond in the areas of Drug+ apps. Our team recently has released an FDA approved class II medical device application, helped remediate several Class I software devices, and we are gearing up for more compelling health applications and patient experiences. For this purpose, we are creating a Medical Device Software Factory (MDSF) that will establish core competencies and expertise in the area of managing the compliance of such devices at a global scale.

The Senior Manager of the Medical Device Software Factory will assist in the creation of the MDSF. The factory will be involved in sourcing software externally as well as working with internal Sanofi development teams to register internally developed SaMDs. In addition, the factory will ensure that the business is compliant with Regulations around launching as well as monitoring SaMDs in various geographic regions and countries. Thus, this role includes working with the business units to educate stakeholders on regulatory and quality compliance needs/requirements. It will also involve supporting business units to leverage the differentiation that such devices can bring by helping them to reduce time-to-market and handling all aspects of compliance.

We are looking for a candidate who has broad knowledge in this area of software medical devices (FDA, CE mark, etc.), deep experience in conducting such work (Quality Agreements, registration, launching, monitoring, etc.), as well as being passionate about helping to build such a group and working closely with the authorities such as the FDA to align with their recent initiatives around Digital Health. The goal is to enable Sanofi to fast-track SaMDs and connected devices and establish Sanofi as a recognized leader in the pharma industry in this regard.

Responsibilities:

  • Help lead the establishment of the medical device software factory within the IA/MED organization in Sanofi to enable the business units to launch SaMDs rapidly and in a compliant fashion, including headcount projections, budget, and timelines for an initial launch as well as growth over time.

  • Partner with the business units to establish appropriate quality agreements with 3rd party software medical device companies that are executed swiftly and in compliance with geographic Regulatory needs, including forming strong stakeholder ties and manage those relationships through influence.

  • Support affiliates and commercial teams in the roll-out of established SaMDs, enabling a global roll-out of solutions by partnering with MED Tech, IS, and other functions as needed.

  • Help develop key KPIs to manage performance of software medical devices and manage the external vender performance to continuously improve quality over time (Life Cycle Management).

  • Help establish high-level and detailed pricing sheets for various types of SaMDs, including what it entails to bring them to market and operationally maintain them in a compliant fashion which differs by geographic region, classification, type of device (app only, app + data backend, etc.).

  • Help establish a financial model to charge the costs of sourcing, launching, maintaining, and monitoring SaMDs back to the business unit / affiliates, given that software is often a freemium model.

  • Collaborate closely with the FDA on their new Digital Health division / group to leverage new opportunities to get Sanofi to a fast track software medical device submission pathway.

  • Provide registration services to the internal software medical device organization so that they can bring new releases into the MDSF.

  • Interact with the various complaint handling groups within Sanofi to ensure products complaints are adequately escalated, triaged, and reviewed as well as perform monitoring of various channels around already launched SaMDs.

  • Help establish and expand the QMS to cover all aspects of the roles and responsibilities of the MDSF.

  • Update job knowledge by staying engaged with the ever evolving Regulatory compliance standards applicable to the global target markets of Sanofi’s SaMD portfolio.

Operational:

  • Help to hire, grow, and manage a cross-functional team that will take on the MDSF duties.

  • Comply with policies and processes and ensure they are communicated, understood, implemented, and maintained at all levels of the organization.

  • Demonstrate excellent partnership and collaboration with other functions and business units within the company to support efficient launch of SaMDs.

  • Demonstrate knowledge, skill and ability to model the Sanofi values and positively communicate the company visions, values, priorities and goals

Requirements:

  • BS in Computer Science or equivalent

  • 10+ years of experience in (software) medical device development as well as operational and fiscal responsibilities

  • 8+ years of experience in working with regulated bodies such as FDA and TUV

  • 3+ years of experience working in the pharma industry

  • 5+ years of experience in developing, registering, launching, and monitoring medical device products in global geographies

  • PREFERRED QUALIFICATIONS:

  • Excellent verbal and written communication skills.

  • Demonstrated initiative and analytical thinking style, good problem solving skills, and ability to comprehend complex problems so that they can be communicated clearly to non-technical stakeholders.

  • Proven track record of being a strong team player, strong leadership skills, and being able to work effectively in a matrix organization. Experience in establishing business operations “from the ground up”

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.

#LI-SA

#GD-SA

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

At Sanofi diversity and inclusion are foundational to how we operate and are embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize that 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 employees, patients and customers.

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