- EBR Systems, Inc. (Sunnyvale, CA)
- The Regulatory Affairs Specialist or Senior Specialist leads the post-approval regulatory activities related to manufacturing and design changes. This ... of experience in regulatory affairs, preferably in the medical device industry. Senior Regulatory Affairs Specialist Bachelor's degree in a scientific,… more
- Becton, Dickinson and Company (San Diego, CA)
- …EU-MDR) Problem solve and escalate regulatory and compliance issues to senior management as necessary Drive continuous improvement in internal processes and ... globally per RA requirements Support the review and approval of product labeling , promotional, and advertising materials as needed. About You: Minimum bachelor's… more
- Teleflex (Morrisville, NC)
- …Clinical and Medical Affairs, Legal/Compliance, Regulatory, and other key departments. The Senior Specialist will partner with key stakeholders in developing and ... business unit's objectives, engage target audiences, and drive sales. In addition, the Senior Specialist will be responsible for integrating efforts of cross… more
- Hologic (Marlborough, MA)
- Senior Regulatory Affairs Specialist Newark, DE, United States Marlborough, MA, United States **Join us as a Regulatory Affairs Specialist -Sustaining, and ... You will provide expertise in sustaining work, supporting product changes, labeling updates, and regulatory process enhancements for both established and evolving… more
- Caring Transitions (Winston Salem, NC)
- …a smooth and stress-free relocation experience. We are seeking a dedicated and experienced Senior Relocation Specialist to join our team in Winston Salem, NC. As ... a Senior Relocation Specialist , you will be responsible...**Responsibilities:** + - Coordinate and oversee the packing and labeling of belongings, ensuring items are handled with care… more
- Abbott (Alameda, CA)
- …Abbott shape the future of healthcare. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory ... review in support of "next-gen" product offerings. . Evaluate proposed design, labeling , and distribution changes for regulatory impact and implement any required… more
- Danaher Corporation (New York, NY)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Regulatory Affairs Specialist I is ... responsible for for pre-market regulatory affairs activities. The Senior Regulatory Affairs Specialist I will work closely with the cross-functional design and… more
- Medtronic (North Haven, CT)
- …license renewal and annual registrations. + Recommends changes for labeling , manufacturing, marketing, and clinical protocol for regulatory compliance. + ... strategies for earliest possible approvals of clinical trials applications. ** SPECIALIST CAREER STREAM:** Typically an individual contributor with responsibility in… more
- Stryker (Redmond, WA)
- We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our **Medical** **Division** to be based **Hybrid** Monday through Wednesday in ... regulatory guidance throughout the product lifecycle, including development, planning, labeling , and claims, while maintaining current product registrations + Assess… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs routine maintenance of approved PMAs, including… 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 ... new or modified, are distributed to appropriate personnel. + Reviews device labeling for compliance with FDA submissions and applicable regulations. + Supports the… more
- ThermoFisher Scientific (Foster City, CA)
- …to our customers' unique needs. We're seeking an upbeat Chemical Management Specialist to manage chemical inventory and ensure labs remain stocked, compliant, and ... approach. + Ability to read and understand SDS documentation and DOT labeling requirements. + Excellent verbal and written communication skills in English.… more
- ThermoFisher Scientific (San Diego, CA)
- …tailored lab services and supply management. We seek a hardworking Lab Specialist to be responsible for chemical inventory, lab support functions like glasswash, ... approach. + Ability to read and understand SDS documentation and DOT labeling requirements. + Excellent verbal and written communication skills in English.… more
- Edwards Lifesciences (Irvine, CA)
- …suggestions on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, and product documentation to assure ... regulatory requirements compliance, consistency, and accuracy **What you'll need (Required):** + Bachelor's Degree + A minimum of 5 years of previous related experience **What else we look for (Preferred):** + Experience in preparing domestic and international… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …**maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist , you will play a crucial role in supporting Medication Management Solutions ... etc.). + Problem-solve and escalate regulatory and compliance issues to senior management as necessary. Drive continuous improvement in internal processes and… more
- J&J Family of Companies (Santa Clara, CA)
- …pressure waves for the treatment of calcified plaque. **Position Overview** The Senior Regulatory Affairs Specialist assisting with Advertising and Promotion ... and effectively meet assigned regulatory requirements for Shockwave Medical. The Senior Regulatory Affairs Specialist combines knowledge of scientific,… more
- Medtronic (Minneapolis, MN)
- …in a more connected, compassionate world. **A Day in the Life** ** SENIOR REGULATORY AFFAIRS SPECIALIST ** In collaboration with leading clinicians, researchers ... and web-based applications that directly affect and improve patient's lives. The Senior Regulatory Affairs Specialist develops strategies for worldwide product… more
- Houston Methodist (Sugar Land, TX)
- …room operations and compliance metrics. At Houston Methodist, the Pharmacy Technician Specialist position serves in an expanded role and is responsible for ... workflow and activities of assigned pharmacy technicians. The Pharmacy Technician Specialist position also performs other specialized functions in the work areas… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management as necessary + Drive continuous improvement in internal processes and ... per RA requirements + Support the review and approval of product labeling , promotional, and advertising materials as needed. **About You:** + Minimum bachelor's… more
- Kelly Services (Mount Pleasant, WI)
- …in document management systems. The position works under the guidance of the Senior Regulatory Affairs Specialist . **Key Responsibilities:** + Create and update ... **Kelly Science & Clinical is seeking a** **Documentation Specialist near Mount Pleasant, WI.** **Temporary/Contract role ~7-8 months** **Shift:** **Monday - Friday… more
