Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the following general areas: Ensuring that their companies comply with all of the regulations and la ...
ws pertaining to their business. Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business, i.e., working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking). Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
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Sr. Director, Regulatory Affairs. Job Location(s). US-IL-Lincolnshire. of Openings. 1. Job ID. 2024-4181. Category. Surgical Robotics Business. Travel. 25%. Overview. Find a Better Way. to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and...
Overview. . Find a Better Way. . to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way. . to improve the lives of others. Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, ...
Job title: Regulatory Affairs Manager. Job location: St. Paul, MN 55117. Experience: 9. Skills. Demonstrates effective change leadership. Builds strategic partnerships to further departmental and organizational objectives. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Education. Bachelor's degree and 9 years of related work experience or an eq...
Sentec seeks an energetic and seasoned. Senior Manager of North American Regulatory Affairs. to lead North-American Regulatory Affairs for our portfolio of products in the United States and Canada. This position reports to the Global Head of Regulatory Affairs and Quality Assurance. Candidates should be versatile, self-driven individuals with a passion for patient care and strategic contribution in a small company environment. This position will ...
Job Description. Job Description. ENT and Allergy Associates, LLP New York & New Jersey's premier ENT and Allergy medical practice, is seeking a self-motivated, people-friendly full time. Regulatory Affairs Associate. at our. Corporate. office location. SUMMARY. The Regulatory Affairs Associate (Compliance Medical Auditor) supports the functions of the Compliance Program for ENT and Allergy Associates, LLP, (ENTA) to be compliant with Federal and...
Job Description. Job Description. ENT and Allergy Associates, LLP New York & New Jersey's premier ENT and Allergy medical practice, is seeking a self-motivated, people-friendly full time. Regulatory Affairs Associate. at our. Corporate. office location. SUMMARY. The Regulatory Affairs Associate (Compliance Medical Auditor) supports the functions of the Compliance Program for ENT and Allergy Associates, LLP, (ENTA) to be compliant with Federal and...
Our partner specializes in their patented resources and ingredients, servicing the community with their profound discoveries globally in the biopharma space. They are in search of a. Regulatory Affairs Specialis. t to play an exciting role across their innovative processes in LA. Schedule. Mon-Fri -8am-5pm (Hybrid). Salary. $85k - $100k. Direct Hire Opportunity. Requirements. Collaborate with teams to develop regulatory processes for pharma produ...
About you. You are a seasoned professional with over 10 years in the Regulatory Affairs space with specific experience with IVD and POC products. You are known as the Regulatory point of contact as you support regulatory needs in all aspects of the business, from product development, to manufacturing and post market needs. You have experience in the past 5 years with US regulatory affairs submissions such as 510(k) and PMA. You are an approachabl...
Job Summary. We are seeking a detail-oriented and knowledgeable Medical Device Regulatory Affairs Specialist to join our team. The ideal candidate will play a crucial role in ensuring that our products comply with all relevant regulations and standards. This position involves working closely with various departments to facilitate the regulatory approval process, manage compliance documentation, and support clinical trials. The Medical Device Regu...
Are you looking for an exciting job where you can put your skills and talents to work at a company you can feel proud to be a part of. Do you want a workplace that will challenge you and offer you opportunities to learn and grow. A position at Xcel Energy could be just what you’re looking for. Position Summary. Administer the rules, regulations, practices, and procedures of the regulatory agencies that have jurisdiction over Xcel Energy's operati...
Role. Regulatory Affairs Associate. Location. Abbott Park, IL 60064. Key Responsibilities. Assist in the preparation, review, and submission of regulatory documents for new and existing medical devices. Support the regulatory team in ensuring compliance with U.S. FDA regulations, EU MDR, and other international regulatory standards. Monitor and track the regulatory submission process, including timelines, document preparation, and regulatory fili...
Job Description. I am. Zach. from. Pioneer Data System, Inc. We have an immediate requirement for. a Regulatory Specialist in Barrington, IL. If you are interested please call me at. (732) 947. 3455. or respond to this email. Position Details. Job Title: Regulatory Specialist. Duration: 12 months. Location: Barrington, IL. Job Description. Scientific Regulatory Responsible for ensuring faultless compliance of recipes and labeling/renovation proce...
