ART MEDICAL is looking for a Regulatory Affairs Specialist to join our growing team. Responsibilities:
* Identify and assess product risks and hazards.
* Support product quality control measures by conducting operations and processes involved in final product safety.
* Review emerging risks and risk control implementation and effectiveness.
* Provide a regulatory framework for risk reduction verification and validation.
* Assess hazards, risks, and controls in a manner consistent with established procedures and practices.
* Support risk management throughout the organization that emerges from non-conformities (MRB), design and process changes, and post-production and device experience (PMS).
* Collaborate with other teams including R&D, V&V, QA, and Customer Support to assess risk control implementation and effectiveness.
* Report to Regulatory Affairs Manager.
Requirements: * Four or more years of experience working in product safety or regulatory affairs for a medical device company.
* Bachelor’s degree in engineering, biology, or another science field (preferred).
* Demonstrated knowledge of risk management standards, including ISO 13485, ISO 14971, ISO 10993, IEC 62366, and IEC 62304.
* Demonstrated knowledge of medical device regulatory standards.
* Demonstrated experience producing protocols, reports, policies, and procedures.
* Understanding of device testing processes, preferably verification and validation.
* Working knowledge of product safety.
* Familiarity with data analysis.
* Strong critical thinking and problem-solving skills.
* Strong organizational skills.
* High English proficiency (reading and writing).
המשרה מיועדת לנשים ולגברים כאחד.