Quality Regulatory Engineer
Datalogic is a global technology leader in the automatic data capture and factory automation markets, specialized in the designing and production of barcode readers, mobile computers, sensors for detection, measurement and safety, RFID, vision and laser marking systems.
Datalogic can boast over 50 years of history, during which it has achieved unique results: approximately 1. 200 patents in multiple jurisdictions; 11 research centers and development (in Italy, USA, China and Vietnam); thousands of prestigious partners and customers deployed over five continents.
The company has grown constantly over the years, thanks to the dedication with which customer needs have always been at the heart of the quality of its products and to the considerable investments in Research & Development, supported by a management capable of looking to the future.
Today, Datalogic Group has approximately 3, 000 employees worldwide, distributed in 29 offices, with 11 manufacturing and repair facilities in the USA, Hungary, Slovakia, Italy, China, Vietnam and Australia.
Datalogic S. p. A. is listed on the STAR segment of the Italian Stock Exchange since 2001 as DAL. MI.
In 2022, the Datalogic Group made significant strides and concluded the year by generating revenue of approximately €655 million.
The Group is headquartered in Bologna, Italy.
Position Information: Datalogic is offering an Quality Regulatory Engineer role, reporting to the Quality Regulatory Manager.
He / she will collaborate with the Global Quality area.
The Quality Regulatory Engineer is responsible for supporting engineers and development activities by sharing regulatory requirements, providing time and cost estimations to achieve the approvals for the list of countries defined, checking samples before regulatory submission, prepare documentation for regulatory submissions.
He/She monitors the activities with the Agencies involved in certification processes and follows up regulatory topics related to new product development, maintenances and renewals of expiring certifications.
In Datalogic the new product development is managed through a gating process called NPD (New Product Development).
The products mainly developed are called FRS (Fixed Retail Scanners), HHS (Hand Held Scanners) and MC (Mobile Computers).
During NPD, periodical meetings are held (CTM = Core Team Meetings and Technical Meetings) to exchange information among teams involved in the projects.
Main responsabilities: Request to Regulatory Agencies / Certification Laboratories quotations and timings to achieve certifications.
Cooperate with them to get the test plan including the number of samples required and how to be prepared; Support development department to guarantee the compliance with applicable; Attend regular Core Team Meetings and Technical Meetings (when necessary) to support new products development; Prepare documentation needed for NPD stages; Verify test reports and certificates received by Regulatory Agencies / Certification Laboratories; Share with the CTM the completion of the activity and provide at the end of the process actual costs and times versus their estimations previously communicated; Keep the certifications updated and renew them before expiring date; Share with the requestors compliance and regulatory documentation when needed.
Requirements: Education: Engineering university degree Languages: Italian, and Fluent English: written and verbal communication Experience: Experience in Product Quality.
Minimum of four years of experience in a related field.
A past experience in Regulatory Topics in I. T. E. , and EMC basic knowledge is preferable.
Other information & Specific Skills: Work experience and training in type approval certifications.
Knowledge of European directives for CE conformity declaration (Low Voltage Directive, EMC, Radio Equipment Directive, NAWI Directive, RoHS, REACH) Knowledge of International Regulatory requirements (USA/Canada, Australia, New Zealand, Japan, South Korea, Taiwan, China) Knowledge in Office tools Capability to work in a team and to sustain strong positions Capability to work under pressure Availability to make some National or International trips (occasionally).
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