- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an ... in the Abbott Vascular Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the … more
- GRIFOLS, SA (Clayton, NC)
- … Specialist I Primary responsibilities for role: Act as Regulatory Affairs representative for specified key products/facilities/equipment. Prepare complex ... Specialist II Primary responsibilities for role: Act as Regulatory Affairs authority for specified key products/facilities/equipment. Manage and prepare… more
- Katalyst HealthCares and Life Sciences (Arvada, CO)
- …medical device industry. (Required) A minimum of 5-7 years of experience in Regulatory Affairs , Engineering, Quality, or related field. Combination of education ... ideally within the orthopaedic industry. Eager to build relationships between Regulatory Affairs and other teams within the organization. bility to communicate… more
- Manatee County, FL (Bradenton, FL)
- …and meetings for the Fleet Manager, Operations Chiefs, and other senior staff, as assigned Prepares correspondence, reports, letters, and meeting minutes ... for the Fleet Manager, Operations Chiefs, and other senior staff, as assigned Maintains division files and records, including some that may be sensitive and / or… more
- Edwards Lifesciences Corporation (Philadelphia, PA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Wurth Baer Supply Company (Vernon Hills, IL)
- …will have expertise in compliance risk management, corporate governance, and regulatory affairs while possessing strong communication, investigative, and ... 5 years of experience in corporate compliance, business ethics, or regulatory affairs . Experience handling investigations, compliance monitoring, and employee… more
- Prescient Healthcare Group (Boston, MA)
- …Strong understanding of drug development across early- and late-stage clinical development, regulatory strategy, and medical affairs Expertise in key therapeutic ... Medical and Scientific Strategy Consulting Who Are Prescient? We are a specialist , strategic partner to global biopharma companies. We provide expertise, derived… more
- Hologic (Marlborough, MA)
- Senior Regulatory Affairs Specialist Newark, DE, United States Marlborough, MA, United States **Join us as a Regulatory Affairs Specialist ... products and processes.** **About the Role:** As a key member of our Regulatory Affairs team, you will be responsible for the ongoing support, maintenance, and… more
- Cook Medical (Bloomington, IN)
- Overview The Senior Regulatory Affairs Specialist responsible for the planning and preparation of submissions to obtain regulatory approvals for new ... and IV medical devices in specific markets. In addition to submissions, the Regulatory Affairs Specialist will serve as a communication liaison between the… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This ** Senior Regulatory Affairs Specialist ** position is an ... in the Abbott Vascular Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the … 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 **Redmond, Washington.** **What you will do** As part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the… more
- AltaGas (Port Huron, MI)
- **Job Description** SEMCO is seeking a ** Senior Regulatory Affairs Specialist ** to support our regulatory goals by researching, developing, and ... driver's license. Must be able to travel, usually to Lansing for regulatory affairs meetings, and occasional overnight to conferences. We offer a competitive… more
- Abbott (Plymouth, MN)
- …and get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist ** to join our team ... 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
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist , Regulatory Affairs - Medical Device Requisition ID: 69746 Date: Jul 10, 2025 Location: Exton, Pennsylvania, US Department: ... environment and planet through our sustainability efforts. **Job Summary** The Sr. Specialist , Regulatory Affairs , Medical is responsible for influencing… 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
- J&J Family of Companies (Santa Clara, CA)
- …of sonic pressure waves for the treatment of calcified plaque. **Position Overview** The Senior Regulatory Affairs Specialist assisting with Advertising ... effectively meet assigned regulatory requirements for Shockwave Medical. The Senior Regulatory Affairs Specialist combines knowledge of scientific, … more
- Medtronic (North Haven, CT)
- …**A Day in the Life** 1) Review promotional material. 2) Perform regulatory evaluation of the change development project/engineering change orders. 3) Responsible ... for MDR recertification and maintenance. 4) Perform regulatory activities per UKCA requirements. Responsibilities may include the following and other duties may be… more
- GE HealthCare (Madison, WI)
- …GE HealthCare establishes best practices in compliance with regulatory requirements. The Senior Regulatory Affairs Specialist will be involved with ... discipline. + 4+ years' experience in a highly regulated industry, preferred in Regulatory Affairs , or equivalent experience through advanced degree or other… 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 ... is responsible for for pre-market regulatory affairs activities. The Senior Regulatory Affairs Specialist I will work closely with the… more
- Globus Medical, Inc. (Audubon, PA)
- …so patients can resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains ... study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
