Electrical Compliance Engineer

5009 Bergen

Stillingstittel Electrical Compliance Engineer

Type ansettelse Fast, heltid 100%

Antall stillinger 1

Frist:
Applications are reviewed continuously

Join Nordic Neuro Lab  and help shape the future of medical technology

Headquartered in Bergen, Norway, Nordic Neuro Lab  is an international and growing company with ambitious plans. To support continued growth and increasing regulatory demands, we are now looking for an Electrical Compliance Engineer to join their Quality & Regulatory Affairs team.

This is a newly established position that will work closely with the VP Quality & Regulatory Affairs and engineering teams across the organization.

This role bridges engineering, product development, testing, verification and validation, and regulatory compliance. You will help ensure that NNL’s products meet applicable international standards and certification requirements while providing compliance support to engineering teams throughout the product lifecycle.

We are looking for someone who combines strong technical understanding with an interest in standards, compliance, certification, technical documentation, and product safety.

This role offers a unique opportunity to help shape and develop NNLs' compliance capabilities while working with innovative medical technology products used worldwide.

• 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.

• Bachelor's or Master's degree in Electrical Engineering, Electronics Engineering, Automation, Physics, Medical Technology, or related technical discipline.
• Experience working with standards, compliance, certification, verification, validation, testing, quality, or regulatory activities.
• Experience with product certification, technical documentation, and engineering documentation.
• Strong technical writing and documentation skills.
• Strong written and verbal English communication skills.

Experience from the medical device industry is highly desirable, particularly within active medical devices and electrical safety standards.

Knowledge of one or more of the following areas is considered advantageous:

• Medical electrical equipment standards for safety and Electromagnetic Compatibility (EMC) (IEC 60601 series)
• Verification and Validation (V&V)
• ISO 14971 Risk Management and ISO 13485 Quality management system
• FDA, MDR, or other regulatory frameworks
• CE marking and product certification processes
• Wireless product compliance (RED, FCC, ETSI)
• Environmental compliance requirements (RoHS, REACH, PPWR, WEEE)
• Product certification processes involving UL, TÜV, CSA, or similar organizations

The ideal candidate is:

• Structured, organized, and detail-oriented.
• Comfortable working with standards, regulations, and technical requirements.
• A strong technical writer capable of…