- Schwan's Company (Marshall, MN)
- …responsible for developing and maintaining product labeling that complies with FDA , FSIS, FNS, and international regulations. This role provides regulatory expertise ... claims for labeling purposes + Create nutrition facts panels in compliance with FDA and USDA labeling regulations + Provide nutrition labeling expertise to internal… more
- Billings Clinic (Billings, MT)
- …by the American Cancer Society, American College of Radiology, HCFA, OSHA and FDA . * Prepares the mammography suite for the patient by assuring cleanliness and ... equipment according to established guidelines by the American College of Radiology and FDA . * Identifies needs and sets goals for own growth and development; meets… more
- Edwards Lifesciences (Portland, OR)
- …MEDDEV 2.7/1 and EU MDR for clinical evaluations. + Experience with FDA PMA applications. + Strong knowledge of scientific research methodology, device development ... process, GCP, ICH guidelines and Global (US FDA , EU MDR, Japan PMDA, China NMPA) regulations. + Experience working in a cross functional, collaborative environment… more
- US Tech Solutions (San Bruno, CA)
- …and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA , Notified Bodies, etc.), and regulatory audits. + Performing product qualification ... of work. + Experience with medical device development standards eg ISO 13485, FDA 21 CFR 820 + Experience working with products incorporating hardware, firmware and… more
- Penn Medicine (Philadelphia, PA)
- …all applicable federal, state, and local regulatory standards (ex OSHA, TJC, DOH, FDA , HIPAA, etc.) + Oversees the POCT process to ensure accuracy and compliance. ... with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) Flexible and readily adopts new processes… more
- US Tech Solutions (San Bruno, CA)
- …and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices ... with SDLC processes and Quality Management Systems (QMS) compliant with US FDA regulations and ISO 13485. **Tool Proficiency:** 1. Demonstrated ability to… more
- ThermoFisher Scientific (Morrisville, NC)
- …and business priorities. + Conduct audits in alignment with relevant standards (eg, FDA , EMA, ICH, ISO). Site Engagement & Audit Logistics + Coordinate logistics for ... + Proficient knowledge of international quality and regulatory standards (such as FDA , EMA, ICH Q-series, ISO 13485). + Lead Auditor certification or equivalent… more
- Terumo Neuro (Aliso Viejo, CA)
- …Supports preparation and hosting activities for third party audits including FDA , Notified Body, corporate and international regulatory authorities' audits. Supports ... multiple projects concurrently, have computer experience and have knowledge of FDA Regulations and Application of Good Manufacturing Practices. 4. Demonstrates… more
- AbbVie (North Chicago, IL)
- …for US and foreign patent prosecution, listing patents in the FDA 's Orange Book, analyzing freedom-to-operate issues, addressing contractual issues, evaluating ... on a broad range of matters involving the Food and Drug Administration ( FDA ), Federal Trade Commission (FTC), Office of Inspector General (OIG), and other applicable… more
- Abbott (Sylmar, CA)
- …and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing ... regulatory requirements. *Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more