- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- …with compliance to MDSAP, European Medical Device Directives (MDD), EU MDR/IVD, FDA , QSR/QMSR, ISO standards, and other applicable regulatory requirements. ... Quality Assurance & Regulatory Manager Valencia & Burbank, CA Company Benefits...ANVISA 665/2022, CMDR, Japan MHLW Ministerial Ordinance No. 169, FDA (21 CFR 820)), FDB, CA-RHB (Radiological Health Branch-product… more
- Sanofi (Swiftwater, PA)
- …are distributed throughout the world. This position guarantees the Quality and Regulatory compliance of products developed, manufactured and distributed by the site ... in accordance with Regulatory requirements and Global Quality policies and standards. This...practical expertise with cGMP requirements including WHO, ICH, US FDA , Canadian BGTD, Australian TGA, EU GMP, Japanese ;… more
- MCKESSON (Dallas, TX)
- …report to the Safety Department within the time frame allotted by the Regulatory Department. You should have: An Associate of Nursing Degree; preferably Bachelor of ... that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively… more
- Pfizer (Groton, CT)
- …study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. Foster a transparent environment that builds strong partnerships ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more
- SOFIE (Somerset, KY)
- …Operations and Technical Services, you'll ensure all quality control systems meet strict FDA and cGMP standards (21 CFR 211 and 212). ESSENTIAL DUTIES AND ... the application of scientific principles and rationales and adherence to regulatory requirements. Collaborate with other production radiochemists and quality control… more
- Christus Health (Sulphur Springs, TX)
- …Quality Control/ Quality Assurance in accordance with MQSA programs and ACR, FDA , and State standards and regulations. Assures that all documentation is accurately ... by State and Federal agencies, the hospital, and other regulatory entities. Coordinates/prioritizes imaging procedures throughout the workday, maintaining a… more
- SOFIE (Somerset, KY)
- …cleaning/sanitation, sterility, environmental monitoring, etc.), customer requirements, and FDA regulations. * Ensure compliance with radiation and laboratory ... complaints from groups of managers, clients, customers, the public required, or regulatory agencies required. * Ability to define problems, collect data, establish… more
- JABIL CIRCUIT, INC (Hunt Valley, MD)
- …technology. Provide engineering and reliability support for all agency audits like FDA , MHRA, and EMA. Maintain all facility drawings of record, facility design ... cGMPs, Good Engineering Practice ('GEP'), Lean and Six-sigma, industry, and regulatory standards and guidelines. Demonstrate familiarity with Microsoft programs like… more
- Rovia Clinical Research (Miami, FL)
- …work/life balance What Makes This Different: You'll have a full-time regulatory and coordinator team supporting you. Transparent communication and rapid study ... preferred. 2+ years of experience as a PI or Sub-Investigator in FDA -regulated clinical trials. Strong clinical judgment and leadership presence. Passion for… 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
- Actalent (Lake Forest, CA)
- …for New Product Development and sustaining engineering projects - Prepare, submit and manage regulatory applications to the US FDA (501 (K), PMA and EU Notified ... - Strong understanding of global medical device regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new...regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new product development, quality, 510(k), Project management, engineering,… 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
- GRAIL (Concord, NH)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… 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
- Takeda Pharmaceuticals (Boston, MA)
- …+ PhD, PharmD, MD, or equivalent strongly preferred. Proven track record working with FDA and regulatory strategy teams in the pharma industry in a policy ... 15 years of combined experience in the pharmaceutical industry, FDA law or policy, and/or scientific or regulatory... FDA law or policy, and/or scientific or regulatory policy. + Strong knowledge of regulations and guidance… 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
- Medtronic (Minneapolis, MN)
- …technical experts to resolve potential regulatory issues and questions from regulatory agencies. + Prepare FDA , European, and Canadian submissions for ... regulatory issues and questions. + Interact directly with FDA and international regulatory agencies on most...+ Interact directly with FDA and international regulatory agencies on most projects/products at reviewer level, with… more
- Bristol Myers Squibb (Madison, NJ)
- … FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical ... compliance of all promotions with approved labeling and /or FDA guidances + Ensure regulatory compliance with subpart E/H and 2253 regulations + Lead training… more
