Job Title: Medical Safety Officer
We are seeking a highly skilled and experienced Medical Safety Officer to join our team. As a key member of our organization, you will play a crucial role in ensuring the safety of our medical devices and providing medical input on risk management reports, product issue assessments, and clinical evaluation reports.
About the Role
The ideal candidate will have a strong background in medicine and experience in risk evaluation and mitigation. You will be responsible for assessing product risk-benefit and offering medical input on risk management reports, product issue assessments, health hazards evaluations, and clinical evaluation reports. Additionally, you will review and provide input on mitigations, labeling, and internal and customer safety training materials directed to minimize patient risk and improve outcomes.
You will also be responsible for monitoring external sources and trends, identifying and calling out emerging issues, and advising on failure investigations and providing medical opinion when deciding on reportability. Furthermore, you will work with customers/users to gather additional medical information/data when required to support investigations.
Requirements
* Doctor of Medicine (MD), Doctor of Osteopathy (DO), or equivalent degree
* Minimum of 3 years clinical or research experience
* Relevant experience or specific training in a Cardiovascular or Interventional specialty
* Ability to use common computer programs (Microsoft Office Outlook, Word, Excel, PowerPoint)
* Knowledge of basic statistical techniques and epidemiological principles
* Knowledge of pre-clinical or clinical research basic concepts
Preferred Qualifications
* Preferred specialties: Neuro-interventional radiology, Interventional Radiology, Neurosurgery, Neurology, Interventional Cardiology, Vascular Surgery or Cardiology
* Experience in risk evaluation and mitigation
* Medical device and/or pharmaceutical industry experience in Health Care and/or device industry
* Clinical study/research experience
* Experience of working with senior leadership within a global healthcare company
* Advanced statistical knowledge (e.g. multivariate data analysis)
* Knowledge of local and international Medical Device regulations
We Offer
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual who is passionate about ensuring the safety of medical devices, we encourage you to apply for this exciting opportunity.