Director, Medical Device Safety
Medical Affairs – Medical Affairs /
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 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 environment
- 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
- Strong communication and presentation skills
$201,000 - $220,000 a year
Commensurate with experience, skills, education and training.
COVID-19 vaccination requirements
At 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 Opportunity
At 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.