- DRT Strategies, Inc. (Arlington, VA)
- …qualification, and strategic capture of new business opportunities with the HHS/ FDA . This includes driving the end-to-end capture lifecycle: market research, ... process. + Demonstrable, hands-on success with business development for the FDA Preferred Experience: + Completion of government business development and capture… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- This position with the Regeneron Regulatory and Commercial Law team will provide proactive and collaborativeetc. **Salary Range (annually)** $238,400.00 - $397,300.00 ... legal advice and counsel in connection with the commercialization of one or more of Regeneron's products, and be part of a legal team supporting cardiovascular, hematology, rare disease, oncology, obesity, and new products. Counsel will be embedded as a core… more
- University of Pennsylvania (Philadelphia, PA)
- …and governmental approval for clinical trials. These trials often include FDA -regulated products, including drugs, medical devices, nutritional products and related ... independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees. Regulatory applications may include new… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the draft CCDS. + Provide US guidance to global team on FDA submissions, meetings, and pediatric development requirements including preparation of documentation, as ... if available, taking into account US regulatory labeling precedence and FDA comments/guidance. + Pre-evaluations and External Partnerships: + Provide broad and… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …or more program(s), including participation in external Food and Drug Administration ( FDA ) meetings, internal core team meetings and providing technical guidance on ... + Develops and leverages working relationships with key personnel/representatives from FDA and oversees communications with regulators. + Work with functional… more
- HRPivot (Tucson, AZ)
- …advanced Class III medical devices through concept, preclinical, and clinical stages to FDA PMA approval. The ideal candidate has deep expertise in design controls, ... product lifecycle. This role is responsible for ensuring compliance with FDA regulations and global standards, driving R&D strategy, and managing cross-functional… more
- Takeda Pharmaceuticals (Lexington, MA)
- …all promotional communications for Takeda's marketed pharmaceutical products meet FDA regulations and industry standards. The department provides strategic ... promotional materials, the Ad/Promo team conducts regulatory research, tracks FDA enforcement trends, and drives process improvements. The Ad/Promo Regulatory… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Jarratt, VA)
- …the results associated with Sanitation KPI's, Internal & External Inspections (USDA, FDA , GFSI) and Customers Requirements. It is responsible for identifying food ... Food Safety, GFSI (BRC & SQF ) and Regulatory requirements (USDA and FDA ). This individual shall ensure the Sanitation Programs adoption and execution directly and… more
- Veterans Affairs, Veterans Health Administration (Greenville, NC)
- …restocking. The incumbent performs daily QA checklist as dictated by the FDA and ACR according to the Mammography Quality Assurance guidelines. Responsibilities ... profiles. c. Performs/documents Quality Control procedures as required by ACR and FDA to maintain accreditation and pass inspections. d. Assists the radiologist in… more
- Medtronic (Lafayette, CO)
- …impact, and ensures timely closure of complaints in compliance with ISO 13485, FDA QSR, and MDR requirements + **Analyzes quality trends and implements corrective ... procedures ensuring compliance with internal policies and external standards (ISO 13485, FDA 21 CFR Part 820, MDR/IVDR). + **Leads audit and inspection readiness**… more
- Actalent (Lake Forest, CA)
- …engineering projects - Prepare, submit and manage regulatory applications to the US FDA (501 (K), PMA and EU Notified Bodies. - Address submission deficiencies - ... or projects - e‑STAR experience = ability to effectively prepare and submit FDA -compliant device filings - Proven track record of successful submissions to, and… more
- System One (East Windsor, NJ)
- …for creating a QA system to notify the US Food and Drug Administration ( FDA ) of illegitimate products, as and when needed. + This position will also review ... guidelines for creating a QA system to notify the FDA of illegitimate products, as and when needed. +...gather the required data and information to notify the FDA of illegitimate products. + Assist the Associate Manager… more
- Evident Scientific (Needham, MA)
- …Regulatory Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards. The position serves as both a hands-on ... Act as US regulatory lead for clinical and medical device products, overseeing FDA submissions (510(k), PMA) and communications. + Ensure ongoing compliance with 21… more
- UNC Health Care (Lenoir, NC)
- …judgment and coordinates and supervises the activities to maintain FDA /ACR requirements. **Responsibilities** : + Performs quality radiographs on patients ... supervises all quality control tests to meet ACR and FDA requirements for digital mammography. + Ensures all quality...completed within the required parameters of the ACR and FDA . + Uses appropriate device to measure viewbox intensity.… more
- Schwan's Company (Minneapolis, MN)
- …our manufacturing facilities, suppliers, and co-packers consistently meet and exceed USDA, FDA , FSMA, SFCR, and other global food safety standards. You will lead ... sites, suppliers, and co-packers to ensure strict adherence to USDA, FDA , FSMA, SFCR, HACCP, SSOPs, and Good Manufacturing Practices, driving continuous… more
- Houston Methodist (Houston, TX)
- …Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on ... Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases… more
- Ascendis Pharma (Princeton, NJ)
- …Affairs, Advertising and Promotion will be an internal expert on US FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug ... to senior management and cross-functional teams regarding shared learnings from FDA advisory comments, recent enforcement actions, and/or guidance documents. +… 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 submissions. ... Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion… more
- Globus Medical, Inc. (Audubon, PA)
- …of 510(k), IDE, and PMA submissions to the US Food and Drug Administration ( FDA ) for class II and class III products. This position entails management of submissions ... to the FDA , requiring working knowledge of products under review and...even-tempered and effective in building working relationships with the FDA , surgeon investigators, researchers, and Globus personnel. This individual… more
- Dentsply Sirona (Milford, DE)
- …role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and ... technical files for CE marking. + Manages communications with FDA and EU notified bodies on behalf of the...EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and… more
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