Vigilance Specialist

We are looking for a Vigilance Specialist to join our team!

Location: Netanya

BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer.

The opportunity:

As a Vigilance Specialist at BioProtect, you will be responsible for complaint handling and for ensuring the quality of complaints is within specifications and in compliance with Medical Device Reporting (MDR), regulatory requirements, and the company’s procedures.

You will also drive cross-departmental collaboration to improve product safety and oversee Post-Market Surveillance (PMS).

In this position you will be asked to:

• Executing vigilance activities for medical devices, with a focus on identifying, evaluating, reporting, and analyzing trends in adverse events and complaints.

• Process events to determine complaint status.

• Perform adequate, accurate, detailed and timely complaint investigations.

• Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.

• Collaborate with relevant teams including technical, Clinical, Field/Sales including returned product analysis

• Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and CE/FDA regulations.

• Support internal systems, methods, and procedures to maintain compliance.

A successful candidate will have the following qualifications:

• At least bachelor’s degree in Life sciences, or related fields

• 4 years of experience in health, clinical, or medical device vigilance

• Strong analytical and problem-solving abilities.

• Excellent communication and interpersonal skills.

• Knowledge of CE/FDA regulatory frameworks and guidelines.

• High level English proficiency, speaking and writing

• Ability to work under pressure and in a multitasking way

• Excellent self – management and interpersonal skills

• Microsoft Office - Excel, PowerPoint

BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.