- Praxair, Inc - a Linde Company (Vancouver, WA)
- …- $112,200 (commensurate with industry experience) What you will be doing: * Provide FDA regulatory and Quality systems support to assigned location ... Quality personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure … more
- Praxair, Inc - a Linde Company (Fresno, CA)
- …- $112,200 yearly (commensurate with experience) What you will be doing: + Provide FDA regulatory and Quality systems support to assigned locations within ... Quality personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate Quality requirements. This employee will ensure … more
- Globus Medical, Inc. (Methuen, MA)
- …technologies. + Support design transfer from R&D to production under ISO 13485 and FDA guidelines. + ** Regulatory & Quality Compliance** + Ensure adherence ... we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the… more
- Unilever (Austin, TX)
- …such as the FDA and FTC. In addition to managing day-to-day quality and regulatory functions, this leadership role requires strategic oversight and close ... be part of it. **JOB SUMMARY** The Senior Director, Quality Assurance and Regulatory Affairs will lead...internal audits and support third-party, FDA , and regulatory inspections. + Generate and analyze quality … more
- WuXi AppTec (Middletown, DE)
- …preparation and maintenance of User Requirements Specifications. + Ensuring compliance with regulatory requirements ( FDA , EMA, cGMP), quality standards, and ... and powder packaging. + Collaborating with cross-functional teams, including R&D, Quality Assurance, Production, and Regulatory Affairs. + Experience in… more
- University of Pennsylvania (Philadelphia, PA)
- …appropriate Sponsor Oversight. The Regulatory Affairs Specialist C, prepares submissions to the FDA in CTD or eCOPY format, conducts quality reviews of all ... Regulatory Affairs Specialist C, prepares submissions to the FDA in CTD or eCOPY format, conducts quality... FDA in CTD or eCOPY format, conducts quality reviews of all regulatory documents for… more
- Boehringer Ingelheim (Ridgefield, CT)
- …development experience/knowledge with a minimum of ten (10) years' experience in Regulatory Affairs, FDA , or equivalent experience in the regulated ... and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with...a minimum of eight (8) years of experience in Regulatory Affairs, FDA , or equivalent experience in… more
- Actalent (Valencia, CA)
- Description The Quality Regulatory Affairs Specialist will be a key contributor to ensuring full compliance with regulatory standards while upholding the ... R&D and Quality teams to assess formulations and claims for regulatory compliance. + Collaborate with internal teams to facilitate certifications from … more
- Dana-Farber Cancer Institute (Brookline, MA)
- …Coordinator works directly for the Clinical Trials Office to complete and oversee FDA regulatory requirements specific to vaccine research or other critical ... Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the...regulatory compliance with all Food and Drug Administration ( FDA ), National Institutes of Health Office of Special Projects… more
- Boehringer Ingelheim (Ridgefield, CT)
- …clinical trial design and results, if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External ... regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RA...and distribution in the US of critical safety or quality communications (including DHCP letters) for assigned projects/products, with… more
- Abbott (Alameda, CA)
- …people's lives. **The Opportunity** Lingo is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables initiative ... Europe, Gulf Countries, and Asia. Overseeing all aspects of quality and regulatory affairs, from design and...or connected health solutions. + Extensive knowledge of global regulatory requirements, including FDA regulations (eg, 21… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …functional representatives from other areas such as R&D, Manufacturing, Medical Affairs, and Quality to review and provide input on regulatory strategy for new ... and support the proposed product claims. + Review CMC changes and determine regulatory reporting category in accordance with FDA guidance for changes to… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director, Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... communication to support both internal and external customers (globally) including the US FDA . Job Responsibilities Note: These statements are not intended to be an… more
- Kemin Industries (Des Moines, IA)
- Overview Kemin Health is hiring an Associate Director of Regulatory /Scientific Affairs and Quality ! In this role, you will be responsible for leading the ... business units' regulatory affairs (RA) and quality assurance (QA)...regulatory entities, including, but not limited to US FDA , EFSA, Health Canada, ANVISA, etc. + Responsible for… more
- Schwan's Company (Minneapolis, MN)
- …it's a seat at the table! Are you a seasoned food safety and quality compliance leader passionate about driving regulatory excellence across the supply chain? ... and Good Manufacturing Practices, driving continuous improvement in food safety and quality standards. Subject Matter Expert on regulatory programs: Serve as… more
- Houston Methodist (Houston, TX)
- …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... **SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
- Conagra Brands (Chicago, IL)
- **Job Summary** Reporting to the Manager Food Safety Quality & Regulatory Affairs, you will independently implement programs within given functional area of the ... safety standards + Collaborate across departments to provide technical support and ensure regulatory compliance, food safety, and product quality . + Evaluate and… more
- Globus Medical, Inc. (Audubon, PA)
- … Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...conformance to 21 CFR regulations. + Assists with other regulatory matters as requested. + Attends FDA … more
- Sumitomo Pharma (Little Rock, AR)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct… more
- Dentsply Sirona (Milford, DE)
- …device industry. + Experience with leading regulatory submissions and managing regulatory projects. + In-depth knowledge of FDA 510(k) and international ... communication skills. + Prior technical writing experience and proven track record with FDA and EU regulatory submissions. + Excellent interpersonal skills. +… more