We are looking for a Regulatory Affairs Specialist to join our team!
Location: Tzur Yigal
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.
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 creation, and maintenance of regulatory files, assist in regulatory submission, annual reports, registrations, and listings.
In this position you will be asked to:
• Manage the overall customer complaints activities in the company, including:
o Investigates & document customer complaints according to applicable regulatory requirements.
o Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.
o Proactive collaboration with cross functional team members to get resolution on customer complaints.
o Risk assessment of customer complaints
o Compile and submit reportable events to relevant regulatory authorities in a timely manner.
o Timely closure of customer complaints
o Handle recalls and field actions, if required.
• Maintain regulatory files. Maintain and update regulatory authorizations, such as 510(k)s, and CE dossiers for EU. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. Support approval in other regions as required.
• Recognize potential regulatory issues from product development through the manufacturing process including review of ECOs for regulatory compliant, including management of registration, as applicable.
• Management of annual reports and renewal of licenses to ensure compliance with local regulatory requirements.
• Stay abreast of standards, regulatory procedures and changes in regulatory climate.
• Authors new or revised site procedures as assigned.
• Establishment and/or approval of documents require regulatory impact such as: Clinical Reports, Clinical Evaluation, PMS report, Essential Requirements, Product Risk Analysis etc.
• Review product labels and promotional material for compliance with applicable regulations standards.
• Participants in internal and external quality system audits and providing regulatory input. Assist in preparing response to regulatory authorities’ questions within assigned timelines.
• Serve as a substitute Management Representative and PRRC
A successful candidate will have the following qualifications:
• 4-5 years’ related experience in similar position in a medical device manufacturing 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)
• 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.
* משרה זו פונה לנשים וגברים כאחד.