Regulatory Affairs and Compliance Engineer

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.

- 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).