- Abbott (Atlanta, GA)
- …a best place to work for diversity, working mothers, female executives, and scientists This ** Regulatory Affairs Specialist II ** will work on-site out of ... + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification is a...in the Medical Device industry. + Regulatory Affairs Professionals Society Certification is a plus. Apply Now… more
- Seattle Children's (Seattle, WA)
- Serves as a subject-matter expert in quality assurance and regulatory support for clinical research at Seattle Children's Research Institute. Guides and supports all ... submission to local and commercial IRBs. Assesses, analyzes, and implements regulatory requirements, policies, and guidance documents; creates and follows standard… more
- Cook Medical (Winston Salem, NC)
- Overview The Regulatory Affairs Specialist II develops regulatory strategies,obtains and maintains approvals, and serves as a communication liaison ... situations and environments with minimal supervision. Qualifications * Minimum 2 years regulatory affairs experience with medical devices* Bachelor's degree in… more
- Medtronic (Mounds View, MN)
- …in a more connected, compassionate world. **A Day in the Life** The Senior Principal Regulatory Affairs Specialist will play a key role in creating ... inclusive of hardware and software components. The senior principal specialist will work directly with new product development and... regulatory affairs group to support regulatory submissions worldwide for Class II medical… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... to support business needs in a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as Regulatory… more
- Abbott (Alameda, CA)
- …place to work for diversity, working mothers, female executives, and scientists This **Senior Regulatory Affairs Specialist ** will work on-site out of our ... technology. **The Opportunity** As an individual contributor, the Senior Regulatory Affairs Specialist will support...input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical… more
- Medtronic (Minneapolis, MN)
- …innovation in a more connected, compassionate world. **A Day in the Life** The ** Regulatory Affairs Specialist ** is responsible for developing regulatory ... international submissions and obtaining and maintaining approval for products. Additionally, the Regulatory Affairs Specialist is responsible for assessment… more
- Teleflex (Chelmsford, MA)
- Sr. Regulatory Affairs Specialist **Date:**...and international. 3 years of experience with Class I, II or III medical devices. * Proven history of ... that make a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies,… more
- Abbott (St. Paul, MN)
- …female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist ** to join Abbott's Vascular Division ... vascular disease. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to...Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus.… more
- Actalent (Davis, CA)
- Job Title: Regulatory Affairs Specialist Looking...a candidate that has at least 2-5 years of regulatory experience within Medical Device Class II . ... registrations, ISO 13485 knowledge Location:Davis, CA Responsibilities: + Oversee the regulatory affairs process for new and existing diagnostic products,… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Lead Regulatory Affairs Specialist oversees the preparation and submission of ... to the Food and Drug Administration (FDA) for class II and class III products. This position entails development...study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting… more
- Abbott (Plymouth, MN)
- …on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced **Senior Regulatory Affairs Specialist ** to join our team on-site in ... Plymouth, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory … more
- Edwards Lifesciences (Irvine, CA)
- …our beautiful campus in Irvine, California.** **How you will make an impact:** The **Sr. Regulatory Affairs Specialist ** you will support the execution of RA ... opportunity to take on the maintenance and completion of regulatory approvals and clearances of some of our revolutionary...understanding of global regulations relevant to medical devices, Class II and/or Class III devices + Full knowledge and… more
- Abbott (Alameda, CA)
- …working with Class II , Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. . Experience with 510(k) ... glucose levels with our new sensing technology. The Opportunity The Principal RA Specialist -Business Partnerships will work on-site out of our Alameda, CA location… more
- Abbott (Alameda, CA)
- …working with Class II , Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. + Experience with either ... glucose levels with our new sensing technology. **The Opportunity** The **Principal RA Specialist - US New Product Introduction** will work on-site out of our… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... domestic and international regulatory environments. Working in...understanding of global regulations relevant to medical devices, Class II and/or Class III devices + Solid knowledge and… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... domestic and international regulatory environments. Working in...understanding of global regulations relevant to medical devices, Class II and/or Class III devices + Full knowledge and… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... international regulatory environments....understanding of global regulations relevant to medical devices, Class II and/or Class III devices strongly preferred + Experience… more
- Edwards Lifesciences (Irvine, CA)
- …more about BD at bd.com **How you'll make an impact:** + Represent the regulatory function on manufacturing and product development teams to provide input on ... regulatory requirements, including presenting alternatives for meeting ...understanding of global regulations relevant to medical devices, Class II and/or Class III devices + Full knowledge and… more
- MyFlorida (Tallahassee, FL)
- REGULATORY SPECIALIST II - 79011169 Date: Apr 29, 2025 The State Personnel System is an E-Verify employer. For more information click on our E-Verify Website ... . Requisition No: 852049 Agency: Business and Professional Regulations Working Title: REGULATORY SPECIALIST II - 79011169 Pay Plan: Career… more
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