Medical Device Electrical Compliance Engineer

NordicNeuroLab AS

New Jersey

On-site

USD 90,000 - 140,000

Full time

14 days+
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Benefits offered by this job

Relocation to Bergen

Job summary

NordicNeuroLab seeks an Electrical Compliance Engineer to join its Quality & Regulatory Affairs team in Bergen, Norway. The role bridges engineering, product development, testing, verification, validation, and regulatory compliance across the product lifecycle.

The successful candidate will ensure NordicNeuroLab's medical technology meets international standards and certification requirements, while supporting engineering teams and coordinating with external laboratories and certification

Qualifications

  • Degree in Electrical/Electronics Engineering, Automation, Physics, Medical Technology, or related field.
  • Experience with standards, compliance, certification, verification, validation, or testing.
  • Strong technical writing and English communication skills.
  • Knowledge of medical electrical equipment standards (IEC 60601) is highly desirable.
  • Familiarity with ISO 14971, ISO 13485, FDA, MDR, or CE marking is advantageous.

Responsibilities

  • Interpret and apply international standards and regulatory requirements for electrical and electronic products.
  • Support engineering teams in translating regulatory requirements into practical design, testing, verification, and validation activities.
  • Review product designs, technical solutions, test plans, and engineering documentation from a compliance perspective.
  • Develop and maintain compliance and traceability documentation.
  • Support verification and validation activities throughout product development and sustaining engineering.
  • Coordinate compliance and certification activities with external laboratories, testing facilities, and certification bodies.
  • Contribute to product risk management activities related to electrical safety and compliance.
  • Support regulatory submissions and technical documentation for global markets.
  • Assess the compliance impact of product changes, component obsolescence, and design updates.

Skills

Electrical engineering
Regulatory compliance
Technical writing
English communication
Standards & certification

Education

Bachelor's or Master's in Electrical Engineering / related field

Job description

NordicNeuroLab seeks an Electrical Compliance Engineer to join its Quality & Regulatory Affairs team in Bergen, Norway. The role bridges engineering, product development, testing, verification, validation, and regulatory compliance across the product lifecycle.

The successful candidate will ensure NordicNeuroLab's medical technology meets international standards and certification requirements, while supporting engineering teams and coordinating with external laboratories and certification

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