Cardiology-Non-Invasive Other job located in New York

(Login for Information)® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years! The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres. 

We are searching for passionate people looking to make a difference in the medical device industry. By joining (Login for Information)® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our customer is ultimately the patient. 

POSITION TITLE: Medical Affairs Director4

SHIFT HOURS: 8:00am to 5:00pm (days)

LOCATION: Onsite at (Login for Information) in Victor, NY 

SALARY PAY RANGE: $150,000yr to $220,000yr 

The Medical Affairs Director provides medical and scientific leadership in support of global regulatory submissions, clinical evaluation, and post-market surveillance.  The Medical Affairs Director leads medical and scientific initiatives across our product platforms. The Medical Affairs Director also leads a Medical Liaison Team supporting a variety of other surgical specialties, which may include general surgery, urology, and neurology. The Medical Affairs Director also engages key opinion leaders on device efficacy, safety, and future product development needs. This role is critical in shaping clinical development strategies, guiding regulatory submissions, and supporting cross-functional teams to ensure the safe and effective use of our products. The Medical Affairs Director leverages clinical and research experience to direct and provide expert opinion on and review of relevant risk assessment documentation related to LSI medical devices throughout the design and development process. The Medical Affairs Director also leads the Surgical Science Team, including overseeing the conduct of in-house and external simulated tissue, ex-vivo animal, in-vivo animal, and cadaver studies and usability studies, including developing scientific protocols, lab procedure plans, lab research plans, and final reports. The Medical Affairs Director also works with the Surgical Science Team to publish papers on LSI’s technology, research, and surgical procedures using LSI technology in world class medical and scientific journals.

REPORTS TO: Executive Director of Regulatory Affairs and Quality

ESSENTIAL FUNCTIONS:

• Spearheading the creation of documentation related to targeted clinical studies regarding LSI devices, including investigation brochures, scientific protocols, Institutional Review Board (IRB) or Ethics Committee (EC) submissions, case report forms, training materials, and final reports.
• Leveraging expertise and knowledge in surgery and surgical procedures, medical diagnosis, and treatment standards to collaborate on clinical evaluation plans, clinical evaluation reports and benefit risk analysis for regulatory submissions.  Identifying clinical evidence gaps, proposing and/or leading the execution of evidence development strategies to address them.  Aligning clinical strategies with commercial objectives.  
• Providing medical and scientific leadership in preparing global regulatory submissions.
• Overseeing the generation, analysis, and communication of scientific data from pre-clinical and clinical evaluation of devices.  This includes contributing to and reviewing clinical study reports.  
• Leveraging clinical and research experience to direct and provide expert opinion on and review of relevant risk assessment (uFMEA, pFMEA, PHA, FRA) documentation related to LSI medical devices throughout the design and development process.
• Contributing clinical expertise to health risk assessments, health hazard evaluations, and adverse event reports as needed.   Supporting post-market surveillance.

EDUCATION & EXPERIENCE:

• Experience as either a Nurse Practitioner, Physician Assistant, or a Fully Licensed Physician is required.  Accordingly, one of the following respective degrees is required:
  1. Master of Science in Nursing (MSN)
  2. Doctor of Nursing Practice (DNP)
  3. Master of Physician Assistant Studies (MPAS)
  4. Master of Science in Physician Assistant Studies (MSPAS)
  5. Doctor of Medicine (MD)
  6. Doctor of Osteopathic Medicine (DO)

This is not an exhaustive Job Description.  Please view full posting here: (Login for Information)

(Login for Information)® is an equal opportunity employer and does not discriminate based on any legally protected status or characteristic.

Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran