Norm Compliance Officer

Job title:

Norm Compliance Officer

Company:

SIRE Group

Job description

The Company
Our client is one of the top global technology companies known for its innovations in healthcare technology, consumer electronics, and lighting. Founded in 1891, it has originally started as a manufacturer of light bulbs but has since evolved into a leader in medical technology and health solutions.Role Description
As a member of the Norm Compliance team, you will be responsible for supporting Norm Compliance activities and deliverables for IGT systems, ensuring adherence to all relevant mandatory international and national regulations. You will participate in a cross-functional development team, representing the Norm Compliance team, and will be involved in developing and executing the standards and compliance plan.Responsibilities
– Identify applicable standards and regulations for the products being developed, such as the IEC 60601 series, IEC 62304, IEC 62366-1, and EU MDR.
– Outline how the required standards and regulations will be incorporated into evidence for demonstrating compliance within the Standards and Compliance plan.
– Create project deliverables related to Norm Compliance responsibilities.
– Assist designers and testers in interpreting and testing standards and regulations concerning the technical design of IGT products.
– Organize and complete all evidence necessary for obtaining product certification from the independent certifying agency.
– Provide technical support to the Regulatory Affairs department in preparation for submissions to regulatory bodies and countries.Requirements
– Bachelor’s degree or higher in a technical field, health sciences, or a related discipline.
– 3-5 years of experience in Software and/or Hardware Testing/Engineering or similar roles within a complex environment.
– Background in the global medical devices industry is a strong plus.
– Knowledge of product safety standards (e.g., IEC 60601) is preferred.
– Familiarity with other national and international regulations is an advantage.
– Well-developed project management skills are preferred.
– Proven experience in improvement activities and audits is an advantage.

Other Information
Interested? Feel free to contact me for further details!53536

Expected salary

Location

Best, Noord-Brabant

Job date

Fri, 27 Sep 2024 22:09:55 GMT

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