Post Marketing Surveillance Leader

We are looking for a PMS Leader 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:

In this role, you will be responsible for regulatory affairs activities including customer complaints handling, assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. In addition, assist in maintenance of regulatory files, annual reports, registrations, and listings.

In this position you will be asked to:

• Manage communication with FDA and other Regulatory Authorities, Regulatory Sponsors and Authorized Representatives regarding AE incidents and Recalls of company devices.
• Complaint Handling, Adverse Event Reporting, & Vigilance/Trend Reporting process owner; Responsible for content of the processes and their correctness & completeness
• Investigates & document customer complaints according to applicable regulatory requirements.
• Serve as a liaison between Clinical Affairs, Production, and Complaint Handling to ensure Post Market Surveillance (PMS) processes are executed end-to-end
• Review complaint trend analysis, clinical evaluation reports, risk management reports and FMEAs.
• Assures compliance of local QMS procedure and updates as required.
• Authors new or revised site procedures as assigned.
• Assess the impact of new and updated standards
• Review and determine the impact of change controls for existing devices, including labeling and management of registration, as applicable.

A successful candidate will have the following qualifications:

• Experience from a medical device company
• Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QSR)
• Experience with managing customer complaints, risk analysis
• Excellent English language skills (verbal and writing)
• Relevant degree (e.g., biomedical engineering or related science / technical discipline)

Bonus Points:

Experience with Class III implantable medical devices

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.