Tempus AI · 1 week ago
Associate Director of Regulatory Affairs
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Artificial Intelligence (AI)Biotechnology
H1B Sponsor Likely
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Responsibilities
Developing and leading global regulatory strategies to support business objectives
Leading 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 scale
Developing and executing premarket and postmarket regulatory project plans and strategies, including assessments of change controls
Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal records
Work closely with business leadership to ensure regulatory strategy aligns with commercial goals
Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently
Qualification
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Required
Experience with complex medical devices, such as some combination of: Software and artificial intelligence based devices, Clinical decision support software, Medical imaging, Oncology, Cardiology
Experience with: Premarket Approval (PMA) applications, de novo Requests for Reclassification, 510(k)s, Investigational Device Exemption (IDE) requirements
Ex-US, CE Marking, UKCA registration, performance studies as required under IVDR and MDR
Software validation and risk management
Cybersecurity in medical devices
Machine learning validation requirements
Lifecycle management of medical devices/IVDs
Changes to medical devices or IVDs, including those that trigger reporting or regulatory submissions
Relevant sections of 21 CFR 820, ISO 13485, IMDRF, Good Clinical Practice, CAP/CLIA, other quality system standards
Strong communication, presentation and interpersonal skills
Experience leading cross-functional teams of subject matter experts
Experience working in a startup-like environment
Experience interacting with regulators
Ability to work well with quality, clinical, medical, bioinformatics, and laboratory teams across a variety of therapeutic areas
Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs
Excellent attention to detail
Strong project management skills and the ability to execute on project plans in a fast-paced environment
Scientific background
Bachelor of Science in a scientific discipline (biology, chemistry, engineering)
Minimum of 7+ years of experience in Regulatory Affairs experience related to medical devices
Knowledge of engineering concepts and biology with ability to evaluate device performance data and develop testing plans
Preferred
MS, MSE or PhD preferred.
Company
Tempus AI
Tempus is making precision medicine a reality by applying AI in healthcare, deriving insights from our expansive library of clinical data and molecular data.
H1B Sponsorship
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guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (52)
2022 (73)
2021 (75)
2020 (32)
Funding
Current Stage
Public CompanyTotal Funding
$1.34BKey Investors
GoogleBaillie GiffordT. Rowe Price
2024-06-14IPO· nasdaq:TEM
2022-10-20Series Unknown· $100M
2022-10-20Debt Financing· $175M
Recent News
2024-10-24
MarketScreener
2024-06-05
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