- Integra LifeSciences (Princeton, NJ)
- …new treatment pathways to advance patient outcomes and set new standards of care. The Sr . Regulatory Labeling Design Project Specialist manages ... goals, regulatory compliance, and cost management/process efficiency goals. The Sr . Regulatory Labeling Design Project Specialist will collaborate… more
- Abbott (Santa Clara, CA)
- …complex changes to on-market products. + Assessing the regulatory impact of labeling , manufacturing and design changes for IDE approved products, 510(k) or ... restore health and improve quality of life through the design and provision of device and management solutions for...Clara, CA currently has an on-site opportunity for a ** Senior Regulatory Affairs Manager - Transcatheter** **Mitral… more
- Terumo Neuro (Aliso Viejo, CA)
- **12359BR** **Title:** Sr Labeling Lead **Job Description:** Lead project teams in developing, finalizing, and implementing product labels, instructions for use, ... policies and procedures. + Collaborate and provide guidance to Labeling Design team to ensure labeling... labeling in medical device field. **External-Facing Title:** Sr Labeling Lead **Posting Country:** US -… more
- Teleflex (Chelmsford, MA)
- Sr . Regulatory Affairs Specialist **Date:** May 8, 2025 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** ... make a difference in patients' lives. **Position Summary** The Sr . Regulatory Affairs Specialist (SRA) will develop...ensure compliance with design controls and review design documentation to confirm regulatory requirements are… 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 in Advertising/ Labeling , you will play a crucial role in ... Directive, EU Electromagnetic Compatibility Directive, etc.). * Problem-solve and escalate regulatory and compliance issues to senior management as necessary.… more
- Caldera Medical (Westlake Village, CA)
- Senior Regulatory Specialist Located in Westlake...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 worldwide regulatory bodies. From developing and authoring regulatory … more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role ... Team_ + Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product… more
- Takeda Pharmaceuticals (Boston, MA)
- …alignment with TAU/MPD Labeling Lead, coordinates the process to obtain IFU labeling approval by Labeling Senior Management Cross-functional team (Global ... compliance with applicable regulatory requirements. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …standards consistent with both Corporate and Business Unit policies, while meeting all labeling and other regulatory requirements. The position will require an ... process. + This individual monitors internal and external regulatory observations and trends and implements changes across the...level in a global company. + Strong background in labeling in relation to product design and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …improve life by advancing the care of patients with life-threatening diseases. The ** Sr . Clinical Supply Manager** is a leader that inspires teams while providing ... includes all elements of the clinical supply chain from the protocol design through manufacturing to distribution and inventory management of clinical supplies at… more
- Mitsubishi Chemical Group (Memphis, TN)
- ** Sr . Environmental Specialist (2000)** + Title: Sr . Environmental Specialist + Group Company: Mitsubishi Chemical Methacrylates + Location:Memphis, TN Group ... has a strong heritage of delivering excellence in the design , development and manufacture of some of the world's...of the global Dow Jones Sustainability World Index as recognition of our beliefs, focus, and effort. **Our Culture**… more
- Caldera Medical (Westlake Village, CA)
- Sr . Quality Engineer Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the Hiring Manager: The Quality Engineer helps to direct ... efforts to ensure that the company's products conform to quality and regulatory standards, establishes and maintains quality assurance procedures and controls, and… more
- Hyundai Autoever America (Irvine, CA)
- 10535 - Sr . Backup and Storage Engineer Location - Irvine, CA Purpose: The Sr . Backup and Storage Engineer is responsible for the design , installation, ... operational support efforts, project implementations, vendor coordination, and backup strategy design across a multi-site hybrid environment. The ideal candidate has… more
- ThermoFisher Scientific (Bohemia, NY)
- …or helping find cures for cancer. **Location/Division Specific Information:** Clinical Labeling Services, part of the Clinical Trials Division, located in Bohemia, ... New York provides leading clinical label design , production and management services for the pharmaceutical and biotechnology industry. Our advanced inspection… more
- Takeda Pharmaceuticals (Boston, MA)
- …plan or study design , including potential impact on timeline or product labeling , ensuring the primacy of patient safety. + Mentors GSLs and PV Scientists with ... knowledge. **Job Description** **About the role:** Join Takeda as a Senior Medical Director, Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will… more
- Abbott (Alameda, CA)
- … design , verify and validate, sustain very low-power analog front-end design and battery-powered embedded systems per applicable regulatory standards for ... appropriateness. #software **What You'll Do** + Ensure that electrical design and test equipment meet applicable industry and medical...+ Work with project teams on risk files and labeling for compliance to regulatory standards. +… more
- ThermoFisher Scientific (Austin, TX)
- …more drug classes, including deep knowledge of clinical program and study design , relevant endpoints, safety considerations, and current regulatory and ... and in the future. **Location/Division Specific Information** Join Thermo Fisher Scientific as a Senior Medical Director based in the United States and be part of a… more
- Integra LifeSciences (Braintree, MA)
- …what's possible and making headway to help improve outcomes. The Sr . Regulatory Affairs Specialist is a seasoned senior professional role responsible for ... regulations in the US, EU, Canada and globally. The Sr . Regulatory Affairs Specialist is responsible for...+ Identify strategies to ensure compliance and maintenance of Regulatory Affairs product files ( design dossiers, periodic… more
- Abbott (Alameda, CA)
- …preparation and review of regulatory submission to authorities + Evaluate proposed design , labeling , and distribution changes for regulatory impact and ... for diversity, working mothers, female executives, and scientists This ** Senior Regulatory Affairs Specialist** will work on-site...in the US. In this role, you will provide regulatory input on design and development activities… more
- Bayer (Cambridge, MA)
- …and diverse minds to make a real difference, there's only one choice.** ** Senior Director, Global Regulatory Leader-IVD** The Senior Director, Global ... strategies. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of this role, Senior Director, Global Regulatory Leader-IVD are to: **Develop and… more