Director, Medical Device Safety
Company: Recor Medical
Location: Palo Alto
Posted on: October 2, 2024
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.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 Vice President, 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
- Perform 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, MBBS
- Minimum of 3-5 years medical safety and vigilance with
knowledge of US, European, and other global regulations
- Experience with post market safety surveillance is a plus
- Experience in medical devices or combination products is
strongly preferred
- Strong collaboration skills with cross-functional teams
- Strong critical thinking skills
- Ability to work independently
- Strong communication and presentation skills
- Active Medical license preferred
- Located within commutable distance to Palo Alto with the
ability to be onsite 5 days per week (minimum of 3 days per
week)$234,750 - $269,200 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 not
discriminate 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, Rancho Cordova , Director, Medical Device Safety, Executive , Palo Alto, California
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