• Establish access management policies and standards and keep them current. • Plan and execute initiatives that improve access management capabilities. • Work with peers to automate onboarding, lifecycle and deprovisioning of privileged accounts. • Manage the entire service delivery process, from planning and implementing service strategies to monitoring and reporting on service performance. • Establish policies, procedures, and standards through periodic review and change management. • Support regulatory requirements and perform audits.

Symmetrio is recruiting for our client for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. This role will focus on FDA 510(k) submissions and regulatory pathways for Software as a Medical Device (SaMD) within a global, multinational environment.    Key Responsibilities  - Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products  - Develop and execute regulatory strategies supporting product development and commercialization  - Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance  - Interpret FDA guidance related to medical device software and digital health technologies  - Partner with global regulatory teams to support international regulatory initiatives

• Facilitate ceremonies such as Daily Scrums, Plannings, and Retrospectives in a remote and international environment. • Collaborate with Product Managers to ensure backlog readiness, delivery and prioritization. • Monitor sprint progress, team capacity, and delivery health, communicating risks, dependencies, and delivery status to relevant stakeholders. • Track and analyze delivery metrics such as velocity, cycle time, and sprint predictability to support transparency and planning. • Facilitate coordination across teams and project stakeholders to manage dependencies and ensure alignment. • Conduct structured 1:1s with team members to maintain alignment and support team delivery. • Ensure delivery teams operate at a sustainable pace while delivering high-quality outcomes aligned with customer needs. • Promote and implement best practices, methodologies, and tools to improve team efficiency and culture.

• Own the T&S Charter and Enforcement Framework • Build and Run the Investigations Engine • Lead and Develop the T&S Team • Embed T&S into the Expert Lifecycle • Lead T&S's Relationship with Product and Engineering