Senior Regulatory Affairs Program Lead
Summary
The Senior Regulatory Affairs Program Lead is responsible for developing and executing global regulatory strategies to support the approval and lifecycle management of medical devices. This role provides strategic regulatory leadership, partners with cross-functional teams, and ensures compliance across global markets.
Responsibilities
Lead and coordinate complex regulatory submissions and approval activities with global regulatory agencies.Develop regulatory strategies to support new product development, product changes, and ongoing market approvals.Provide regulatory guidance to cross-functional teams throughout design, development, commercialisation, and post-market activities.Oversee the preparation, review, submission, and maintenance of regulatory files including (k)s, IDEs, PMAs, HDEs, annual reports, technical documentation, and change notifications.