- THE MARKET (St. Thomas County, VI)
- …adherence to all applicable health and safety regulations including Food Safety and regulatory duties required in the department. Pay has room for growth depending ... the following motions: bending, twisting, squatting and reaching. . Exposure to FDA approved cleaning chemicals. . Exposure to temperatures: <32 degrees Fahrenheit… more
- AdaptHealth LLC (San Diego, CA)
- …not limited to those put forth by: CMS, Department of Health, DOT, FDA , OSHA, and the company's accreditation organization * Manage logistics team providing daily ... with return demonstration and accountability as evidenced by achieving operational and regulatory audit goals. * Assist in resolving patient equipment problems under… more
- Whole Foods (Austin, TX)
- …Team Member safety and security standards. * Ensures compliance with relevant regulatory rules and standards. * Develops, coaches, mentors, and motivates Team ... the following motions: bending, twisting, squatting, and reaching * Exposure to FDA approved cleaning chemicals * Exposure to temperatures <32 degrees Fahrenheit… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- This position with the Regeneron Regulatory and Commercial Law team will provide proactive and collaborative legal advice and counsel in connection with the ... advisor to multiple internal stakeholders, including the commercial, medical affairs, regulatory , HEOR, corporate affairs, and compliance teams. Counsel will advise… more
- AbbVie (Washington, DC)
- …the lead within the US Policy & Analytics (USPA) team for all legislative and regulatory policy developments related to FDA . The Director will work with internal ... our goals. Core Responsibilities + Identify, track, and analyze FDA legislative and regulatory developments that impact AbbVie and its products. + Work… 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 ... to ensure regulatory compliance with all Food and Drug Administration ( FDA ), National Institutes of Health Office of Special Projects (NIH OSP), and… more
- J&J Family of Companies (Horsham, PA)
- …subject to applicable laws, regulations, guidelines and company policies (including FDA regulatory promotional practice laws, regulations, policies, guidelines ... pharmaceutical or biopharmaceutical industry is required. + Working knowledge of FDA regulatory promotional practice laws, regulations, policies, guidelines and… more
- ITG Brands (NC)
- …tobacco and nicotine products. Serve as a strategic legal advisor on FDA regulatory matters, including product submissions, labeling, marketing, enforcement, and ... regulatory industry (tobacco, pharmaceuticals, medical devices). + Strong background in FDA regulatory matters, state- regulatory compliance, regulatory… more
- Boehringer Ingelheim (Ridgefield, CT)
- …two (2) specialized areas of pharmaceutical law, one of which must be FDA Regulatory (eg, patient support programs, market access, patient assistance support) ... programs, access, Specialty Care/ Rare Disease pharmaceutical products. + Experience in FDA prescription drug regulatory matters including experience in the… more
- Xcelerate Solutions (Frederick, MD)
- …trend knowledge points and risks through the medical portfolio + Track and trend FDA regulatory intelligence + Assist with full lifecycle project management and ... Program Analyst IV - Medical Regulatory & Acquisition Strategy Xcelerate Solutions is seeking...for pharmaceutical development and within the constraints of the FDA approval process + Plan and provide input to… more
- Unilever (Austin, TX)
- …CFR Parts 111 and 117. The position will also serve as the primary liaison with regulatory agencies such as the FDA and FTC. In addition to managing day-to-day ... issues as necessary. + Conduct internal audits and support third-party, FDA , and regulatory inspections. + Generate and analyze quality KPIs and trends and… more
- Actalent (Valencia, CA)
- …Regulatory , Regulatory submission, Regulatory affairs, dietary, regulatory affairs certification, Fda , Labelling, Regulatory compliance Additional ... supplement, pharmaceutical, food and beverage or related industry. Thorough understanding of FDA regulations (21 CFR) and other global regulatory requirements… more
- Astellas Pharma (Northbrook, IL)
- …in early and late-stage drug programs. + Provide expert guidance on diagnostic regulatory pathways including IVDR (EU), FDA (IDE, 510(k), PMA), and other ... record working in pharma of successful submissions under IVDR and FDA diagnostic regulatory pathways for drug clinical studies and companion diagnostics. +… more
- ITG Brands (NC)
- …the development and submission of Premarket Tobacco Product Applications (PMTAs) and other regulatory filings to the FDA Center for Tobacco Products (CTP). The ... a relevant scientific discipline and possess deep expertise in regulatory strategy, toxicology, clinical studies, and FDA ...in regulatory strategy, toxicology, clinical studies, and FDA engagement. - WHAT YOU WILL DO + Lead… more
- Schwan's Company (Minneapolis, MN)
- …and Preventive Controls Qualified Individual (PCQI), providing expert guidance on regulatory requirements, product safety, labeling compliance (USDA/ FDA ), and ... leadership: Act as the main point of contact for regulatory agencies including FSIS, FDA , CFIA, and...of contact for regulatory agencies including FSIS, FDA , CFIA, and State/Military authorities. Lead corporate recall processes,… 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 ... + Prior technical writing experience and proven track record with FDA and EU regulatory submissions. + Excellent interpersonal skills. + Ability to work… 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 ... Manager. Assists in the preparation of periodic reports for FDA + Develops appropriate regulatory reports and...periodic reports for FDA + Develops appropriate regulatory reports and associated documentation in accordance with SOPs… more
- Dentsply Sirona (Sarasota, FL)
- …worldwide. **Job Summary:** **The Senior Manager of Regulatory Affairs supports regulatory affairs activities for US FDA 510k submissions, Health Canada ... Experience with leading regulatory submissions and managing regulatory projects + In-depth knowledge of FDA ...managing regulatory projects + In-depth knowledge of FDA regulations and international standards (eg, ISO 13485, MDSAP,… more
- Abbott (Plymouth, MN)
- …communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other ... timely manner to support Abbott customers. + May interface directly with FDA and other regulatory agencies if so directed. + Support all Company initiatives as… more
- AbbVie (North Chicago, IL)
- …Advise internal customers who may contribute to regulated communication on Regulatory / FDA issues including Public Affairs, Clinical Development, Legal, and ... Description Responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or… more
