- Hologic (Louisville, CO)
- …documentation control processes within a Quality Management System (QMS). + Familiarity with FDA Quality System Regulations and ISO 13485 standards is a plus. + ... compliance with quality standards. + Hands-on experience in industries regulated by FDA or ISO 13485 is highly preferred. + Familiarity with integrating new… more
- Mentor Technical Group (Guayama, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Is responsible for overseeing work order activity compliance with regulatory requirements (ie FDA , DEA, OSHA). + Improve work force productivity and work quality by… more
- Tecomet (Kenosha, WI)
- …policies and procedures, Good Manufacturing Practices (GMP) and FDA regulations. **Qualification Requirements** **Credentials/Experience:** + High school diploma ... and interpret documents such as safety rules, operating and maintenance instructions, FDA regulations, and procedure manuals. + Ability to read and understand… more
- Edwards Lifesciences (Draper, UT)
- …environment * Experience managing small to medium IT projects * Experience with FDA guidelines for Software Quality and Systems Validation * Proven expertise in ... Prior experience working in complex global business environment * Prefer experience with FDA guidelines for Software Quality and Systems Validation is a plus *… more
- Penn Medicine (King Of Prussia, PA)
- …Are you living your life's work? Summary: + Accountable for tracking of all FDA regulated infusion devices (pumps), as well as non- FDA regulated equipment, used ... in the provision of home infusion therapy. Responsibilities: + Ensures accurate record keeping of DME equipment for clinical and reimbursement purpose. Registers pumps to patients when required, per a generated ancillary supply list, to establish a patient… more
- Kelly Services (Petaluma, CA)
- …+ Participate in internal/external audits and ensure regulatory adherence (GMP, FDA ). **Qualifications:** + Bachelor's or Master's degree in Microbiology, Biology, ... Biosafety Level 1 and 2 laboratory protocols. + Knowledge of GMP and FDA regulations as applied to microbiology labs. + Hands-on experience running and maintaining… more
- Colgate-Palmolive (Piscataway, NJ)
- …high-quality commercialization. + Maintain all required documentation under **GMP/GLP** per FDA /ICH guidelines as required. + Documentation may include R&D project ... experience + Knowledge of Regulatory environment across the globe + Knowledge of ICH/ FDA guidelines for stability and testing of new drug products **Compensation and… more
- Cook Medical (Bloomington, IN)
- …as necessary.- May interface with internal or 3rd party audits. (eg FDA , Notified Body, etc.)- Drive continuous improvement efforts through facilitating, leading, ... and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements. Must work and… more
- Globus Medical, Inc. (Audubon, PA)
- …specifications for new product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project + Managing all ... and market plans + Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + Partnering with the operations department to setup… more
- L3Harris (Mason, OH)
- …well as L3Harris policies and procedures. + Monitor and support compliance with FDA regulations for imports; Temporary Import under Bond shipments; ATA Carnets and ... Control (OFAC), US Customs regulations and other participating government agencies (ie FDA , FCC, ATF). + Experience working with freight forwarders and customs… more