Tempus
Associate Director of Regulatory Affairs
Tempus, Chicago, Illinois, United States, 60290
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
At Tempus, we are building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Senior Manager/Associate Director of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine.
ResponsibilitiesDeveloping and leading global regulatory strategies to support business objectivesLeading and assisting with submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc.Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scaleDeveloping and executing premarket and postmarket regulatory project plans and strategies, including assessments of change controlsWorking closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal recordsWork closely with business leadership to ensure regulatory strategy aligns with commercial goalsMaking regular reports to our executive team, operationalizing leadership direction quickly and efficientlyWhat your background might look like
Experience with complex medical devices, such as some combination of:Software and artificial intelligence based devicesClinical decision support softwareMedical imagingOncologyCardiologyExperience with:Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, Investigational Device Exemption (IDE) requirementsEx-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDRSoftware validation and risk managementCybersecurity in medical devicesMachine learning validation requirementsLifecycle management of medical devices/IVDsChanges to medical devices or IVDs, including those that trigger reporting or regulatory submissionsRelevant sections of 21 CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standardsStrong communication, presentation and interpersonal skillsExperience leading cross-functional teams of subject matter expertsExperience working in a startup-like environmentExperience interacting with regulatorsAbility to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areasResponsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needsExcellent attention to detailStrong project management skills and the ability to execute on project plans in a fast-paced environmentScientific backgroundBachelor of Science in a scientific discipline (biology, chemistry, engineering), MS, MSE or PhD preferred.Minimum of 7+ years of experience in Regulatory Affairs experience related to medical devicesKnowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans
#LI-SH1 #LI-Remote
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
At Tempus, we are building a regulatory team that will adopt creative approaches as we develop regulated medical devices and seek marketing authorization from FDA. Our Senior Manager/Associate Director of Regulatory Affairs will work closely with our scientists, engineers, clinicians, quality professionals, and legal team to support our efforts to advance personalized medicine.
ResponsibilitiesDeveloping and leading global regulatory strategies to support business objectivesLeading and assisting with submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc.Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scaleDeveloping and executing premarket and postmarket regulatory project plans and strategies, including assessments of change controlsWorking closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal recordsWork closely with business leadership to ensure regulatory strategy aligns with commercial goalsMaking regular reports to our executive team, operationalizing leadership direction quickly and efficientlyWhat your background might look like
Experience with complex medical devices, such as some combination of:Software and artificial intelligence based devicesClinical decision support softwareMedical imagingOncologyCardiologyExperience with:Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, Investigational Device Exemption (IDE) requirementsEx-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDRSoftware validation and risk managementCybersecurity in medical devicesMachine learning validation requirementsLifecycle management of medical devices/IVDsChanges to medical devices or IVDs, including those that trigger reporting or regulatory submissionsRelevant sections of 21 CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standardsStrong communication, presentation and interpersonal skillsExperience leading cross-functional teams of subject matter expertsExperience working in a startup-like environmentExperience interacting with regulatorsAbility to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areasResponsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needsExcellent attention to detailStrong project management skills and the ability to execute on project plans in a fast-paced environmentScientific backgroundBachelor of Science in a scientific discipline (biology, chemistry, engineering), MS, MSE or PhD preferred.Minimum of 7+ years of experience in Regulatory Affairs experience related to medical devicesKnowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans
#LI-SH1 #LI-Remote
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Additionally, for remote roles open to individuals in unincorporated Los Angeles - including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.