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Senior, Regulatory Affairs Specialist

Job Description

Magic Leap is seeking a Regulatory Specialist with experience working in an advanced technology environment. Candidate must be able to interact with product development teams, Sr. Management. external suppliers and regulatory bodies. The candidate should also possess regulatory knowledge of Domestic and International regulations and guidance. Expertise in project management, global product licensing & registration and the preparation of regulatory submissions is required.

Responsibilities

• Work with Senior Management to establish a viable regulatory pathway for market entry.
• Plan, coordinate and prepare document packages for regulatory submissions
• Create and maintain correspondence/files for foreign regulatory bodies.
• Review and approve all product labeling, marketing literature and packaging
• Draft regulatory process maps and standard operating procedures for companywide QMS. (Quality Management System)
• Build effective and sustainable cross functional relationships
• Research and compile all country registrations and regulatory marks for device, package and website labeling for new products.
• Maintain all regulatory registrations required for market entry.
• Support day to day regulatory and QMS operations.
• Draft and review regulatory SOP’s for standardizing work streams
• Participate in change management and review and approve Engineering Changes
• Support internal/external audits and implement corrective/preventive action as needed
• Stay current on regulatory changes that effect the AR/ VR industries.

Qualifications

• 5+ years of experience in working in regulatory environment/ 7-10 years in a regulated industry with associates’ degree
• Proficiency with MS and Google software applications.
• Willingness to write technical documents (e.g., QMS processes, regulatory submissions)
• Strong interpersonal, communication and problem solving skills.
• Ability to work independently
• An understanding of the principles of document control.
• Ability to understand technical product specs and be able to effectively communicate details to regulatory bodies as needed
• Ability to work in fast paced environment
• Excellent communication skills
• Planning, scheduling & Priority setting
• Able to work with limited supervision

• Associates Degree/Bachelors preferred or relevant work experience

Additional Information