regulatory affairs Jobs in new york

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CMC Regulatory Affairs Manager

TechSpace Solutions Inc.

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Remote

Third Party, Contract

Job Title : CMC Regulatory Affairs Manager Location : Remote Duration : 12 Months Responsibilities: Leading project teams, ensuring maintenance of team records and process-related documentation i.e., process maps, job aids, project trackers, checklists, etc.Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for
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Posted 3 days ago | Updated 3 days ago

Senior Regulatory Affairs Specialist (Medical Devices)

ApTask

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Remote

Contract

Job Title: Senior Regulatory Affairs Specialist (Medical Devices) Location: Remote Duration: Long term contract Job Description: -Subject Matter Expert for Class II and Class 510(K) submission. -Hands on experience with 510(k) authoring, submissions, and communicating with the FDA. -Hands on experience with software as a Medical Device (SaMD) and validation requirements and applicable consensus standards. Key Responsibilities- -Authoring US FDA 510(k) submission using eSTAR submission tool.
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Posted 4 days ago

Regulatory Affairs Senior Manager

Software Guidance & Assistance

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Hawthorne, New York, USA

Full-time

Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Senior Manager for a FULL TIME assignment with one of our premier Pharmaceutical Services clients in Hawthorne, NY. Responsibilities: US Agent for all Firm's products, responsible for communication between the FDA and manufacturing sites. Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and approved applications Lead, guide and t
Posted 60+ days ago | Updated 11 hours ago

Principal Regulatory Affairs Specialist (Remote)

Medtronic

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Remote or Los Angeles, California, USA

Full-time

Careers that Change Lives Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's w