Vice President, QA/RA/Clinical
Company: Talis Biomedical
Posted on: June 18, 2022
About the Company
Our purpose at Talis is to advance health equity and outcomes by
delivering accurate infectious disease testing in the moment of
need, at the point of care.
While timely diagnosis of infectious diseases is critically
important to enable effective treatment, testing is primarily
performed in centralized laboratories, which require samples to be
shipped for processing, delaying the return of results by days.
Point-of-care testing solves this problem by delivering the timely
information necessary for clinical care.
To deliver our purpose we focus on three things:
Putting customers and patients first
Making Talis a great place to work
Living our values to Dream Big, Share Our Screens, Serve Others,
Bring Our "A" Game, and Build Trust
Vice President, QA/RA/CA to provide high-level strategic leadership
to Talis's Regulatory Affairs (RA), Quality Assurance (QA), and
Clinical Affairs (CA) teams.
Work collaboratively and cross-functionally with R&D,
Manufacturing, Commercial, and Marketing executives to provide
clinical and regulatory expertise to complete project deliverables,
often under stringent timelines.
Develop and lead an engaged team that is innovative, agile,
receptive of change, and willing to constantly learn in a rapid
Expert regulatory and clinical development leadership of all
pre-clinical and post-market studies for IVD medical device(s)
including study design, clinical monitoring, safety, risk, and
feasibility assessments, site selection, clinical compliance, and
successful submission execution.
Be actively involved in the development of clinical protocols,
Investigator Brochures, Clinical Study Reports, TMF, and other
various critical study documents.
Ensure operational oversight to clinical teams, communicating trial
objectives, timelines, budgets, and overseeing proper resource
allocation, data management, and statistical analysis.
Ongoing development of Quality Management System (QMS), including
SOP creation, adhering to FDA and GxP requirements, training,
management, and oversight of audits & certifications.
Support overall business strategy by maintaining robust regulatory
compliance, develop quality standards, establish vendor and
external KOL relationships, and ensure inspection-readiness at all
SME for continuous QA/RA/CA improvement
Review and execute on all relevant departmental policies,
procedures, and trainings.
Mentor, lead, and develop employees, focused on performance
management, living our values, and succession planning.
Who You Are
Bachelor's degree required in a science or engineering field. - MS,
MBA, PhD preferred.
Extensive experience in -the biotech/Medical Device space,
specifically with IVD. Knowledge of Software as a Medical Device
(SaMD) products is a benefit.
15+ years combined experience in Quality Assurance, Regulatory, and
Experience in smaller sized companies/start-up environments
Developed strong relationships with regulatory authorities.
5+ years of direct management experience.
Able to organize, prioritize and execute to achieve company
Proficiency with ISO 13485, MDSAP, IVDR and GxP requirements.
Basic knowledge and familiarity with software terminology and
testing, validation, and user requirements, and IQ/OQ/PQ.
Demonstrated success spearheading medical device products through
FDA, Health Canada, and the EU as well as ROW.
Extensive experience hosting regulatory audits/inspections as the
primary point of contact.
Expert level project management skills to build and execute on
Cross functional leadership skills for interaction with internal
executive team members, as well as with external Board of
Directors, investors, and other 3 rd parties.
Talis offers a -comprehensive -health and -well-being -benefits
-programs, -long-term equity incentives, -time-off policies, a
401(k) -retirement savings plan -with -an -immediate -Company
match, Education Assistance Program, a rotating suite of snacks,
Monday breakfasts, Happy Hours, other fun company events and more!
Best of all, join us by working at a growing company like Talis
with -dedicated and collaborative employees committed to making a
difference in Health Care.
Talis is proud to be an equal opportunity workplace. All aspects of
employment decisions will be based on merit, competence,
performance, and business needs. We do not discriminate -on the
basis of -any status protected under federal, state, or local law.
We celebrate diversity and are committed to creating an inclusive
environment for our colleagues.
More About Talis:
Built on a foundation of world-class science and engineering, we
are developing the Talis One platform, a sample-to-answer,
cloud-enabled molecular diagnostic platform that could be rapidly
deployed to distributed diagnostic settings in the United States
and around the world to diagnose infectious disease at the
point-of-care. The Talis One platform comprises a compact
instrument, single-use test cartridge, and innovative software
including a central cloud database. This system is designed to
provide central laboratory levels of accuracy and be operated by an
Talis has raised more than $500 million to date and went public in
February 2021. We were granted Emergency Use Authorization by the
FDA for our Talis One TM COVID-19 Test System in November 2021 and
are in further testing stages and preparations for commercial
Keywords: Talis Biomedical, Fremont , Vice President, QA/RA/Clinical, Executive , Fremont, California
Didn't find what you're looking for? Search again!