- Medtronic (Boulder, CO)
- …software - Part 1: General requirements for product safety + United States FDA Device Software Functions related Guidance's + United States FDA Interoperability ... - Security Risk Management for Device Manufacturers + United States FDA Pre-Market and Post-Market Product Cybersecurity Guidance's + European Commission's Guidance… more
- ThermoFisher Scientific (Wilmington, NC)
- …monitoring-are scientifically sound, risk-based, and compliant with global regulatory requirements ( FDA , EMA, WHO, PIC/S, and ICH Q7-Q10). The incumbent will serve ... that all validation strategies are science- and risk-based, in accordance with FDA Process Validation Guidance, Annex 15, and ICH principles, supporting PSG's… more
- SAIC (Silver Spring, MD)
- **Description** SAIC is seeking a Scientific Systems Engineer to support FDA operations. This role provides critical scientific computing support to FDA ... and Research (CDER) in **Silver Spring, MD.** Our team supports FDA 's scientific mission through comprehensive technical services including hardware management,… more
- Cardinal Health (Mansfield, MA)
- …analytical method transfer protocols following the regulatory requirements (ICH, USP and FDA ). + Perform investigations of Out of Specification (OOS) test results as ... needed follow FDA guidelines. + Maintain compliance with relevant regulatory requirements...Maintain compliance with relevant regulatory requirements (eg ICH and FDA ) related to stability studies and data documentation. +… more
- Lundbeck (Deerfield, IL)
- …managing end-to-end process of promotional material inventory, fulfillment, and compliance, FDA 2253 submissions and field operations day to day support. The ... role ensures timely and accurate submission of promotional materials to the FDA 's Office of Prescription Drug Promotion (OPDP). The specialist will also coordinate… more
- Parexel (Providence, RI)
- …development. * Participate in promotional review committees, ensuring alignment with FDA regulations and company standards. * Collaborate with global teams to ... ensure consistency across markets while meeting US-specific requirements. * Maintain compliance with FDA 21 CFR Part 202 and other relevant US regulations. * Support… more
- Merck (Rahway, NJ)
- …using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971). This position will ... requirements for medical device and drug combination products (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971)...to identify gaps against internal standards, regulatory expectations (eg, FDA , EMA), and industry best practices, generate action plans… more
- Astellas Pharma (Northbrook, IL)
- …includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. ... focus on North American requirements. + Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major… more
- Caris Life Sciences (Phoenix, AZ)
- …across laboratory, operational, and customer-facing functions to maintain compliance with FDA , ISO 13485, CAP, and CLIA requirements while driving data-informed ... Caris' global Quality System and Regulatory framework, maintaining compliance with applicable FDA , ISO 13485, CAP, and CLIA standards. The analyst contributes to… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Sarasota, FL)
- …executed as required by both internal quality programs/systems as well as required by FDA and USDA. + Lead the FSQ Team through the Export Product Commercialization ... New & Existing Local Purveyors (and their teams) in FDA compliance. + Oversee Quality Auditing programs including SQF...have complete understanding of all USDA FSIS HACCP & FDA FSMA regulatory requirements. Proficiency in Microsoft Office programs… more