Oversees and directs all regulatory activities for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Develops and implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc. Provides counsel to and manages the regulatory team. Ensures timely preparation of organized and scientifically valid applications. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies. Selects, develops and evaluates employees to ensure the efficient operation of the function.
Manages regulatory responsibilities associated with the development, support, and deployment of the Company’s non-medical and medical device software products.
Manages development and implementation of regulatory strategies and plans to support the timely introduction of new products and the possible preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings.
Monitors and assesses domestic and international Regulatory developments (e.g. Federal Register publication/notices, FDA and EU guidelines, etc.) related to the Company’s products.
Reviews product labeling to ensure conformance with applicable regulatory requirements and/or approved product claims.
May serve as a contact with affiliates to achieve international registration of products.
Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.
Supports global regulatory initiatives and collaborates with quality and regulatory professionals across the Roche organization.
Expertise in Software as a Medical Device (SaMD) and related regulations and guidance documents in U.S., Europe, Canada, and APAC. For example, 21st Century Cures Act and related FDA guidance documents, Medical Device Regulation (MDR), EU guidance documents, IEC 62304, ISO 13485, ISO 14971, AAMI TIR45, AGILE development, etc.
Bachelor’s degree or equivalent
Master's degree/PhD. or equivalent (preferred)
Typically, a minimum of 6+ years of related Regulatory Affairs experience
Working knowledge of software and software development
Excellent oral and written communication skills
Consistently neat and accurate reporting
High attention to detail
Excellent organizational skills
Proficient in MS Office applications
Excellent people skills: tact, collaborative, able to communicate with personnel at various levels in the organization
US FDA Class I, II and III medical device experience
EU MDD experience
Internal Number: 201906-119378
About Roche Molecular Solutions
Doing now what patients need next
We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world.
That is why we come to work each day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world.
We are Roche.