Director, Medical Device Safety
Company: ReCor Medical, Inc.
Location: Palo Alto
Posted on: November 18, 2023
Job Description:
At ReCor Medical, we are pioneering Ultrasound Renal Denervation
(uRDN) therapy to treat hypertension, the leading cardiovascular
risk factor in the world. With our Paradise--- uRDN System, we're
on a mission to provide the millions of people who suffer from
hypertension with a non-drug and minimally invasive option to lower
their blood pressure. Join us on our journey and make a meaningful
impact on the lives of people around the globe.Position Summary:The
Director, Medical Device Safety will be responsible for leading
global safety and imaging for clinical and commercial use of ReCor
Medical products. Responsibilities include managing a growing team
of physicians and scientists who support Safety and Imaging
teams.The position requires experience leading and developing
vigilance/safety reporting processes globally and
developing/managing teams to support those goals. This position
requires device and medical safety background within clinical
trials and commercially. The position will work cross-functionally
with the global organization. Managers in Clinical Safety and
Clinical Imaging will report into this position. The position
reports to the Senior Director, Medical Affairs.Responsibilities
including but not limited to:
- Develop global vigilance/safety reporting processes and a team
to support those goals
- Responsible for oversight of Clinical Safety Team and Imaging
Team
- Lead and support clinical safety and imaging team managers
- Responsible for the monitoring, signal detection, analysis,
interpretation, and documentation of medical safety information
including safety events, literature, and other sources
- Ensure timely and appropriate global reporting of clinical and
commercial products
- Manage governance goals (DSMB, Imaging Corelab, independent
adjudicators, and others)
- Responsible for strategic safety and imaging communication to
cross-functional ReCor teams
- Participates in strategic decision making for maintaining and
developing global safety database
- Support writing, review, and submission of ad hoc reports,
narratives, IFU, annual/quarterly reports, CER, PMCF, PSUR
- Manage Health Hazard Assessments
- Support Medical Affairs safety guidance to internal and
external teams
- Perfom medical risk benefit assessments and provide support to
Quality Affairs and R&D
- Align ReCor Medical Affairs with global/Otsuka Medical
Devices
- Promote a growth environmentRequirements:
- Minimum of a MD/DO, PhD
- Active medical license (preferred)
- Minimum of 3-5 years medical safety and vigilance with
- Knowledge of US, European, and other global regulations
- Experience in medical devices (preferred)
- Required collaboration with cross functional teams
- Required critical thinking
- Self-motivated
- Strong communication and presentation skills$242,084 - $284,162
a yearCommensurate with experience, skills, education and
training.COVID-19 vaccination requirementsAt ReCor Medical, we
care, we collaborate, we challenge, and we create. Pursuant to
these core values, we are focused on the health and safety of our
employees, as well as the teamwork essential for innovation of our
pioneering technology.COVID-19 vaccines will be required for all
ReCor US office employees effective June 10, 2021, as well as all
new US office employees joining our company.Fully vaccinated
persons are those who are > =14 days post-completion of the
primary series of an FDA-authorized COVID-19 vaccine. Equal
Employment OpportunityAt ReCor Medical, we value bringing together
individuals from diverse backgrounds to develop new and innovative
solutions for patients. As an equal opportunity employer we do
notdiscriminate on the basis of race, color, religion, national
origin, age, sex (including pregnancy), physical or mental
disability, medical condition, genetic information gender identity
or expression, sexual orientation, marital status, protected
veteran status, or any other legally protected characteristic.
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Keywords: ReCor Medical, Inc., Palo Alto , Director, Medical Device Safety, Executive , Palo Alto, California
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