ART MEDICAL Ltd
  • 8 active jobs (view)

  • Published: May 9, 2022
Category
Job Type
Level of education
Undergraduate
Spoken Language needed
Hebrew, English
Level of Hebrew
Fluent
Location of job
Netanya
How many relevant years experience do you require for the role:
More than 3 years

Description

ART MEDICAL is looking for a Regulatory Affairs and Compliance Engineer 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).

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