- Globus Medical, Inc. (Eagleville, PA)
- …Summary** **:** The Assembly Technician is responsible for assembling medical devices in compliance with applicable FDA , state, OSHA, and ISO regulations and ... made to specifications + Tests products and/or subassemblies for functionality or quality . This may include performing test protocols for product qualifications, and… more
- Penn Medicine (Philadelphia, PA)
- …supports the management team and physicians, supports the delivery of high quality care, promotes confidentiality of protected information, shares a passion for ... meetings as assigned and communicates appropriate information to staff + Monitors employee compliance reports and notifies employees when they are due for testing or… more
- GRAIL (Menlo Park, CA)
- …ability to be flexible and creative yet ensuring the clinical trial is executed within compliance of regulations and of the highest quality , and to be able to ... training and management, provides ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, FDA... compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all… more
- Mentor Technical Group (Millbrae, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more
- PDS Tech Commercial, Inc. (Indianapolis, IN)
- …Calibration Technician** . In this role, you'll ensure the reliability and compliance of critical production systems in a state-of-the-art GMP Radioligand Therapies ... facility, supporting the safe and high- quality production of life-saving therapies. **What You'll Do** +...+ Maintain and calibrate radiation detection equipment to ensure compliance with radiation safety programs. + Document work orders,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …**Responsibilities:** + Lead and develop direct report associates to ensure regulatory compliance + Problem solve and escalate regulatory and compliance issues ... effort to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the monitoring,...experience including SaMD/SiMD is a plus + Regulatory and Quality Information Management systems such as SAP, RIM, or… more
- Catalent Pharma Solutions (Greenville, NC)
- …Greenville site. Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer and ... vendor safety, new hire orientation, job site audits, and ensure regulatory compliance across environmental, health, and safety domains. + Ensure adherence to EPA,… more
- Humana (Miramar, FL)
- …for individual patient orders. + Coordinates all supplies recall activities and assures compliance with FDA and company policies for same if applicable. + ... of all routing. + Performs vehicle maintenance to assure compliance with manufacturer's and company fleet management specifications. +...need it. These efforts are leading to a better quality of life for people with Medicare, Medicaid, families,… more
- Sumitomo Pharma (Augusta, ME)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First"… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … Oversight: Offer strategic regulatory advice to cross-functional teams and ensure compliance with FDA , EMA, and Health Canada regulations. Assess regulatory ... Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and risks. + Lead and Manage… more