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Join NordicNeuroLab as an Electrical Compliance Engineer

NordicNeuroLab AS

مكان العمل
BERGEN، VESTLAND
تاريخ النشر
آخر موعد للتقديم
Applications are reviewed continuously
حجم الوظيفة
دوام كامل
نوع التوظيف
دائم
عدد الوظائف
1

تفاصيل الوظيفة

هذه ترجمة آلية لتسهيل الفهم وقد تحتوي على أخطاء. راجع النص الأصلي قبل التقديم.

Join NordicNeuroLab and help shape the future of medical technology   Headquartered in Bergen, Norway, NordicNeuroLab 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.    About the Role 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.     Key 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.   Preferred Background 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.   Valuable Experience 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   Who We Are Looking For The ideal candidate is: Structured, organized, and detail-oriented. Comfortable working with standards, regulations, and technical requirements. A strong technical writer capable of producing clear, accurate, and audit-ready documentation. Able to understand complex technical systems and communicate effectively across disciplines. Self-driven and capable of working independently. Comfortable balancing engineering challenges with regulatory requirements. Motivated by quality, compliance, and continuous improvement.   Why Join NordicNeuroLab? Work with innovative medical technology products used worldwide. Join an international company with ambitious growth plans. Thrive in a collaborative environment where experienced Quality, Regulatory Affairs, and Engineering teams work together to advance innovation. Help shape a newly established role with significant influence and development opportunities. Contribute directly to patient-focused technology that makes a difference globally.   Candidates residing outside Norway are welcome to apply, provided they are willing to relocate to Bergen.   For questions regarding this position, please contact Michelle Kolskår, Head of Sales at Folk AS. Phone: +47 48 13 66 56 E-mail: michelle@folkas.com   Since its establishment in 2004, Folk AS has assisted both Norwegian and international companies in finding highly skilled professionals within technical and administrative disciplines for project-based, temporary, and permanent positions. This is what we do best, and where our expertise lies. Our core values are: ethical, personal, committed, and flexible.   We see opportunities in your competence!
النص الأصلي للإعلان
Join NordicNeuroLab and help shape the future of medical technology   Headquartered in Bergen, Norway, NordicNeuroLab 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.    About the Role 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.     Key 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.   Preferred Background 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.   Valuable Experience 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   Who We Are Looking For The ideal candidate is: Structured, organized, and detail-oriented. Comfortable working with standards, regulations, and technical requirements. A strong technical writer capable of producing clear, accurate, and audit-ready documentation. Able to understand complex technical systems and communicate effectively across disciplines. Self-driven and capable of working independently. Comfortable balancing engineering challenges with regulatory requirements. Motivated by quality, compliance, and continuous improvement.   Why Join NordicNeuroLab? Work with innovative medical technology products used worldwide. Join an international company with ambitious growth plans. Thrive in a collaborative environment where experienced Quality, Regulatory Affairs, and Engineering teams work together to advance innovation. Help shape a newly established role with significant influence and development opportunities. Contribute directly to patient-focused technology that makes a difference globally.   Candidates residing outside Norway are welcome to apply, provided they are willing to relocate to Bergen.   For questions regarding this position, please contact Michelle Kolskår, Head of Sales at Folk AS. Phone: +47 48 13 66 56 E-mail: michelle@folkas.com   Since its establishment in 2004, Folk AS has assisted both Norwegian and international companies in finding highly skilled professionals within technical and administrative disciplines for project-based, temporary, and permanent positions. This is what we do best, and where our expertise lies. Our core values are: ethical, personal, committed, and flexible.   We see opportunities in your competence!
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