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Regulatory Affairs Specialist

Description

Afimilk is a growing global company in the field of Ag-Tech. Our products are multidisciplinary, providing IoT-based management innovative and technological solutions for the dairy farm industry. Our products are connected to over 10 million users worldwide.

Job Description

As a Regulation Affairs Specialist, you will be accountable for leading Afimilk's regulation and safety daily through all the incorporated activities and projects. You will be the company focal point and gatekeeper overseeing and ensuring product regulation throughout the product life cycle.

You will also be the leader in defining and implementing quality regulation and safety processes.

Requirements

Essential Duties and Responsibilities include the following (Other duties may be assigned):

·        Supports new product development by researching standards and regulatory requirements.

·        Acquaintance with European basic, product-related directives (CE, Safety, Radio, EMC, RoHS, food, Batteries, product labeling, self-declarations.)

·        Acquaintance with US & Canada basic product requirements (FCC Radio, food, Safety UL-MET.)

·        Review and evaluate program plans and guidelines for compliance with standards and provide tangible feedback.

·        Perform product assessments to Product Safety requirements by performing in-house testing and preparing detailed reports.

·        Support for all company products regulation throughout the entire life cycle.

·        Day to day, the quality engineering activities include product quality documentation, customer complaints, ECOs, non-conformities, FAI, Document

Control, and corrective field action.

·        Collaborate with Operations, R&D QA, Engineering, and Manufacturing functions to ensure quality standards are in place.

·        Collect, analyze, and interpret statistical data, perform analyses, and provide reports as required.

·        Actively involved in the NPI process


Requirements:

·          Quality Assurance experience in Engineering & manufacturing/NPI environment of multidisciplinary products (Electronics, Mechanic, SW, Testing,

Integration)- with proven expertise in Regulation

·          Ability to read/understand technical documentation

·          Ability to operate and maintain laboratory equipment to conduct Product Safety testing – an advantage

·          Excellent reading, writing, and speaking skills in Hebrew and English.

·          Proven experience in leading quality aspects throughout product life cycle

·          Experience in leading quality projects or project management

Other:

·           Technical ability

·           Experience with Priority ERP system – an advantage

·           Experience in mass-production - an advantage

·           Proficient in documentation

·           High Learning ability

Education

 B.Sc. in Engineering from a leading university or equivalent experience

·           CMQ/OE, CQE – an advantage

Personal Attributes

   Excellent communication skills, both verbal and written in English & Hebrew

·           Self-motivated, self-maintained, and able to take the initiative to solve problems

·           Team player and excellent interpersonal skills

·           Systematic thinking, leadership, and management skills

·           Ability to prioritize workload to meet deadlines

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