Labeling Specialist Consultant I

Experience: Minimum 2 years professional experience prior to this role. Education: Associate Degree/Bachelor's degree or equivalent. Assist in the development of the instructional wording on the outside of the packaging. Ability to learn FDA’s medical device labeling regulations and requirements a must, and FDA-related experience is preferred. Candidate can manage labeling projects, including new product development and sustaining products. Strong emphasis on exceeding customer expectations, while maximizing value and maintaining FDA/ISO and other regulatory compliance. Work as part of the Regulatory Affairs team, but able to liaise with and other functions (e.g., supply chain, legal, clinical, vigilance) to ensure the accuracy of all information included on the label or in the labeling, and providing proofreading support. Participate in project management meetings as needed. Review Document Change Orders for Regulatory compliance, including drawings and labeling changes. Support preparation (markup/annotate and clean) packaging components. Work with vendors/contractors to ensure adequate and timely support. 

Thank you,
Sachin Patil,
510-402-1063
sachin@apninc.com

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