- ThermoFisher Scientific (Carlsbad, CA)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Regulatory Affairs Specialist III - Global Submissions** ... **The Role:** As a Regulatory Affairs Specialist III at Thermo Fisher Scientific Inc., you will have the exceptional opportunity to play a crucial role… more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Specialist III - APAC** will ... team goals and division regulatory priorities. + Provides support to Regulatory Affairs management when working towards resolution of compliance issues,… more
- Abbott (Austin, TX)
- …to work for diversity, working mothers, female executives, and scientists. **The Opportunity** This Regulatory Affairs Specialist III position will work ... and division regulatory priorities. + Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these… more
- Edwards Lifesciences (Irvine, CA)
- …maintaining regular, in-person collaboration. **How you'll make an impact:** As a Senior Specialist , Regulatory Affairs , you work with other functional areas ... patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative...and global regulations relevant to Class II and/or Class III medical devices Aligning our overall business objectives with… more
- Cook Medical (Winston Salem, NC)
- Overview The Regulatory Affairs Specialist I... approvals for new and modified Class I, II, III and IV medical devices in specific markets. In ... addition to submissions, the Regulatory Affairs Specialist will serve as a communication liaison between the Cook manufacturer and the Cook Local Office /… more
- Abbott (Atlanta, GA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist ** to join Abbott's Heart Failure ... in Atlanta, GA. As an individual contributor, the Principal Regulatory Affairs Specialist is responsible... regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist ** to join Abbott's Heart Failure ... Pleasanton, CA. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to...5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs … more
- Medtronic (Minneapolis, MN)
- …and remain a global leader in medical technology and solutions. The **Senior Regulatory Affairs Specialist (Sr. RAS)** develops and executes strategies ... Support (MCS) portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance... requirements and quality standards + Experience with Class III medical devices (PMA) + EU MDR strategy and… more
- Stryker (Portage, MI)
- …people who deliver safe and robust solutions. **What you will do** As the Regulatory Affairs Specialist , you will support Stryker's Acute Care portfolio ... is available at www.stryker.com . We are currently seeking an **Senior** ** Regulatory Affairs ** **Associate** to join our **Acute Care business unit**… more
- Medtronic (Minneapolis, MN)
- …a more connected, compassionate world. **A Day in the Life** The **International Regulatory Affairs Specialist ** is responsible for developing strategies for ... and other duties may be assigned: **Collaborate with the US Operating Unit Regulatory Affairs team and international regulatory colleagues to provide… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on ... devices. Under the mentorship of the Senior Manager of Regulatory Affairs , they are responsible for the...complex global regulatory strategies and preparation of regulatory submissions. The Senior RA Specialist will… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …7. Ability to comprehend technical documents and concepts. **External-Facing Title:** Senior Specialist Regulatory Affairs **Posting Country:** US - United ... **12271BR** **Title:** Sr. Specialist , Regulatory Affairs **Job...as evidenced by successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health… more
- Stryker (Redmond, WA)
- …is available at www.stryker.com . We are currently seeking an **Senior** ** Regulatory Affairs Associate** to join our **Medical Division** , **Hybrid** ... **What you will do** As part of the Medical Regulatory Affairs team, you will work with...Affairs role required. + Previous experience with Class II/ III medical devices preferred. + Previous experience drafting 510(k)s… 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 ... Paul, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory … more
- Stryker (Redmond, WA)
- …an Engineering, Science, or equivalent field + 0-2 years in a Regulatory Affairs role + Previous experience with Class II/ III medical devices preferred + ... ways to simplify, standardize and automate. We are currently seeking an ** Regulatory Affairs Associate** to join our **Medical Division** , **Hybrid** , to be… more
- Medtronic (Irvine, CA)
- …Knowledge and Experience:** . Requires a Baccalaureate degree Minimum of 10 years of regulatory affairs experience or advanced degree with a minimum of 8 years ... Works independently to provide strategic input and technical guidance on regulatory requirements for business-critical and new product development projects +… more
- Edwards Lifesciences (Irvine, CA)
- …at Edwards' Irvine campus. **How you will make an impact:** * Represent the regulatory function on manufacturing and product development teams to provide input on ... regulatory requirements, including presenting alternatives for meeting ...regulations relevant to medical devices, Class II and/or Class III devices * Full knowledge and understanding of EU… more
- AbbVie (Mettawa, IL)
- …level will be determined by the qualifications listed below. Purpose Provides specialist medical and scientific strategic and operational input into core medical ... affairs activities such as: healthcare professional/provider interactions (HCPs, Patients...into and influences the development of asset strategy. Provides specialist medical insights, and executes on data generation, communication,… more
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 66496 Date: Aug 14, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **Who We Are:** At West, we're a dedicated ... Regulatory Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global portfolio of medical… more
- Globus Medical, Inc. (Audubon, PA)
- …so patients can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for ... and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions,...a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,… more