- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply related… more
- LanceSoft (North Haven, CT)
- …that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads projects and collaborates with stakeholders to ... requirements, and the type of device protection required. Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical… more
- Stryker (Weston, FL)
- We are seeking a ** Senior Regulatory Specialist ** to join our Mako and Enabling Technology business within the Joint Replacement Division to be based hybrid ... or Weston, FL. **What you will do** As the ** Senior Regulatory Affairs Specialist ** ,... strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing… more
- Hologic (Marlborough, MA)
- Senior Regulatory Affairs Specialist Newark, DE, United States Marlborough, MA, United States **Join us as a Regulatory Affairs Specialist ... You will provide expertise in sustaining work, supporting product changes, labeling updates, and regulatory process enhancements for both established… 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 ... for for pre-market regulatory affairs activities. The Senior Regulatory Affairs Specialist I...Health Canada filings, and Technical File authoring. + Provide regulatory guidance on product labeling , marketing materials,… 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 ... **What you will do** As part of the Medical Regulatory Affairs team, you will work with the team... guidance throughout the product lifecycle, including development, planning, labeling , and claims, while maintaining current product registrations +… more
- Abbott (Plymouth, MN)
- …get 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
- 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 ... needed for IDE and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs routine… more
- Medtronic (North Haven, CT)
- …submissions, license renewal and annual registrations. + Recommends changes for labeling , manufacturing, marketing, and clinical protocol for regulatory ... **A Day in the Life** 1) Review promotional material. 2) Perform regulatory evaluation of the change development project/engineering change orders. 3) Responsible… more
- Edwards Lifesciences (Irvine, CA)
- …on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, and product documentation to assure ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …self. Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist , you will play a crucial role in supporting Medication ... Directive, EU Electromagnetic Compatibility Directive, etc.). + Problem-solve and escalate regulatory and compliance issues to senior management as necessary.… more
- J&J Family of Companies (Santa Clara, CA)
- …sonic pressure waves for the treatment of calcified plaque. **Position Overview** The Senior Regulatory Affairs Specialist assisting with Advertising and ... assigned regulatory requirements for Shockwave Medical. The Senior Regulatory Affairs Specialist combines... stakeholders to help ensure that changes in product labeling are appropriately reflected in promotions and advertising. +… more
- Caldera Medical (Westlake Village, CA)
- Senior Regulatory Specialist Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for ... Women! In your role as a Sr. Regulatory specialist , you will develop and implement medical device regulatory strategies to obtain timely approvals from… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …regulations (eg, FDA Medical Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management as necessary + Drive ... customer satisfaction + Support the monitoring and interpreting of current and new regulatory requirements and international standards for US and RoW + Support that… more
- Pilgrim's (Greeley, CO)
- **Description** Regulatory Ingredients Specialist Purpose and Scope/General Summary: The Regulatory Ingredients Specialist is part of our Research & ... Development team and reports directly to the Senior Ingredients and Nutrition Regulatory Manager. This role supports the development of food products by… more
- Bio-Techne (Austin, TX)
- …The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory staff to submit regulatory filings and support ... regulatory best practices. + Assess product history, advise on global regulatory strategy, review change controls, and support labeling , promotional, and… more
- GE HealthCare (Madison, WI)
- …GE HealthCare establishes best practices in compliance with regulatory requirements. The Senior Regulatory Affairs Specialist will be involved with ... **Job Description Summary** A trusted regulatory subject matter expert to provide guidance to...regulatory requirements flow-down, advertising and promotion review, product labeling compliance, etc. GE HealthCare is a leading global… more
- GRAIL (Durham, NC)
- …Planned Deviations (DARs), Complaint Handling/Post Market Surveillance, Product Labeling , and Packaging/Distribution. This individual may represent the Quality ... but not limited to all-Quality, Clinical Laboratory Operations,Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Affairs, Supply Chain,… more
- Actalent (El Monte, CA)
- …Oversee pest control programs and sanitation protocols. Verify product labeling and ingredients for regulatory compliance. Investigate non-conformities ... and customer complaints; implement corrective actions. Communicate with suppliers to obtain necessary documentation. Host inspections from USDA, FDA, and local health departments. Travel to branches and vendor sites across the US to ensure quality standards.… 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 ... **Kelly Science & Clinical is seeking a** **Documentation Specialist near Mount Pleasant, WI.** **Temporary/Contract role ~7-8 months** **Shift:** **Monday - Friday… more
