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Director, Regulatory Affairs Medical Devices


This is a Full-time position in Somerville, MA posted April 7, 2021.

Position Overview:Do you want to be on the forefront of medical technology?

Perhaps you would like to try something different, work in an exciting, dynamic field with engaged professionals in a unique team environment.

If so, then maybe medical device regulatory affairs is your calling.This critical and highly visible position offers the successful candidate an opportunity to support a wide range of products, including but not limited to software-based programs, clinical trial technology and connected drug delivery devices, all of which are part of Sanofi’s exciting development pipeline. The ideal candidate:Has experience leading people and values cultural and intellectual diversity.Has experience within a global biotechnology, pharmaceutical, or medical device organization, preferably with a track record of successful software medical device and/or drug combination product regulatory affairs, development, advocacy, or quality oversight.Has experience with connected drug delivery systems, clinical trial technology and/or software as a medical device.  Has significant experience working in a highly-regulated industry and interacting with regulatory authorities.Has experience working in large and complex organizations.Has demonstrated an ability to think outside of the box and assure that Global Regulatory Affairs is recognized as a knowledgeable strategic partner. Has a solid working knowledge of regulatory requirements, health authority expectations, and technical / device industry standards related to software as a medical device, clinical trial technology, and connected drug delivery systems.Key Responsibilities:Leading a team of medical device regulatory affairs professionals.Developing and overseeing innovative and sustainable medical device regulatory strategies covering software as a medical device, connected drug delivery systems and clinical trial technology by balancing regulatory requirements and corporate vision.Building and cultivating strong working relationships with key internal and external stakeholders.Representing Global Regulatory Affairs on due diligence activities and new project initiatives for medical device-related activities.Providing regulatory guidance and advice to global project and development teams.Leading global filing activities for digital health and connected device products.Leading and/or advising on global regulatory assessment of digital properties.Leading device related global health authority interactions.Working closely with internal and external partners to ensure global regulatory risks are identified, communicated, and properly addressed.Engaging with the relevant regulatory bodies and industry groups to influence industry standards and regulations, ensuring that Sanofi’s best interests are represented;Establishing internal regulatory processes and procedures for medical device software and connected devices.​Basic Qualifications:Bachelor’s degree in life sciences or engineering with at least 5 years of relevant software medical device and/or combination products experience or a combination of a Master’s degree and relevant experience.Experience leading cross functional regulatory teams.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 leadership, 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.#GD-SA#LI-SAAt 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.Full time