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Principal Regulatory Affairs Specialists

Hikma Pharmacueticals USA, Inc.
Columbus, OH
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271315424 Job Duties : Serve as a Principal Regulatory Affairs Specialist ...
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for regulatory activities of R&D and/or lifecycle submissions to the U.S. FDA, including, but not limited to the compilation, review, and submission of pre-approval (R&D) and/or post-approval (lifecycle) submissions, such as original applications, amendments & deficiency responses, annual reports, supplements, supplement deficiency responses, and general correspondence for all regulatory submissions with a focus on Chemistry, Manufacturing, and Controls (“CMC”) and Labeling. Provide support in applicable team meetings,...
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Food Regulatory Affairs Specialists

Wyandot Snacks
Marion, OH
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270776057 Food Regulatory Affairs Specialist Marion, OH 43302, USA Req #125 ...
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Monday, February 19, 2024 The Food Regulatory Affairs Specialist will be responsible for ensuring all claims made on packaging are met within regulatory requirements, as well as maintaining good standing with our regulatory bodies. Duties: Maintain certification status of both the facility and individual products with various certifying bodies Generate Nutrition Facts Panels and Ingredient Statements for new products Review packaging to ensure claims are justified Ensure documentation stays up-to-date for both...
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Cylinder Control Specialist

Airgas USA, LLC
Cleveland, OH
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78527693 270665344 R10038624 Cylinder Control Specialist (Open) Location: ...
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Independence, OH - Rockside Woods Blvd - Management - AMG-Corp How will you CONTRIBUTE and GROW? The Cylinder Control Specialist is responsible for cylinder population accuracy, customer cylinder records and branch on-hand cylinder balances through monitoring and maintaining proper controls. This position will coordinate with Regional Cylinder Control, Region VPs of Operations (RPOs), and Gas Coordinators to ensure accurate and timely reporting and compliance to policies and procedures.In Particular you will:...
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Regulatory Affairs Submission Analyst II

PharmaForce, Inc.
New Albany, OH
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78590818 270687711 Nature and Scope Regulatory submissions/operations ...
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professional with experience in complete pharmaceutical development life-cycle management. The focus of this position will be to ensure publishing compliance to FDA, EU and Health Canada regulations. Focus on delivery with excellence while maintaining quality and compliance. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Obtain regulatory documents and initiate eCTD compilation using templates,...
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Senior Regulatory Affairs Specialist

AtriCure, Inc.
Cincinnati, OH
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78171291 269754082 Senior Regulatory Affairs Specialist Cincinnati, OH, USA ...
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* Mason, OH, USA * Minneapolis, MN, USA * Minnetonka, MN, USA Req #1924 Friday, February 2, 2024 AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment...
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Senior Product Labeling Specialist

Steris Corporation
Mentor, OH
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78056493 269474121 Job Senior Product Labeling Specialist Req ID: 40770 Job ...
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Category: Engineering Mentor, OH, US, 44060 Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary As a Sr. Product Labeling Specialist, you will work within Product Engineering with the crucial responsibility for the design, development, approval, and implementation of all product labelling on new and sustaining projects. This position is considered a Hybrid role - Minimum 4...
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Regulatory Operations Intern

Steris Corporation
Mentor, OH
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78056320 269451087 Job Regulatory Operations Intern Req ID: 41447 Job ...
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Category: Intern Mentor, OH, US, 44060 Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary The Corporate Regulatory Department is looking for energetic, dynamic and team-oriented individuals to complement our group's mission to diligently execute critical compliance initiatives. This dynamic role will provide exposure to many of the regulations, standards, and practices that...
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Quality & Regulatory Compliance Specialist (New Grads Welcome)

Steris Corporation
Mentor, OH
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78056166 269405083 Job Req ID: 41629 Job Category: Regulatory Affairs ...
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Mentor, OH, US, 44160 Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary This is an entry-level position.The mission of the STERIS Quality & Regulatory Compliance function is to implement repeatable and sustainable processes to ensure ongoing compliance with domestic and international regulations and standards.This includes evaluating the relevance to all STERIS facilities and...
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Lead, Quality & Regulatory Compliance Auditor

Steris Corporation
Cleveland, OH
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78062833 269405102 Job Lead, Quality & Regulatory Compliance Auditor Req ID: ...
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41518 Job Category: Regulatory Affairs Cleveland, OH, US, 44122 Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Position Summary The mission of the STERIS Quality & Regulatory Compliance function is to implement repeatable and sustainable processes to ensure on-going compliance with domestic and international regulations and standards. This includes evaluating the relevance to all...
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Post Market Vigilance Specialist

Meridian Bioscience, Inc.
Cincinnati, OH
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78045167 269382911 Post Market Vigilance Specialist Job Locations ...
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US-OH-Cincinnati Company Meridian Bioscience, Inc. Department General Administrative # of Openings 1 About Meridian Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that...
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