- Nesco Resource (Plymouth, MN)
- …required. 2 years experience in a health care environment, and/or within a quality/ compliance / regulatory organization in an FDA regulated business preferred. ... reporting decisions per reporting requirements globally. Responsible for creating and submitting regulatory reports to the FDA . Works independently and is… more
- Nesco Resource (New Haven, CT)
- …presentations Deep knowledge of human factor/usability engineering, safety, performance and regulatory compliance (EU and FDA ) requirements of ... of medical device and/or combination products Deep knowledge of regulatory and compliance requirements for device risk...62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820/ISO13485 quality… more
- EY (Chicago, IL)
- …controls. Must have 2 years of experience in at least one of the following regulatory compliance models: SOX, FDA , FERC/NERC, HIPAA.Must have 3 years of ... world for all.IT Risk Advisor, Technology Consulting - Governance Risk and Compliance Technology (SAP) (Manager) (Multiple Positions) (1493800), Ernst & Young US… more
- DivIHN Integration Inc (Research Triangle Park, NC)
- …and proofreading skills with keen attention to detail. Strong understanding of regulatory requirements, including FDA and GMP. Experience with process mapping ... instructions, training documents and other procedures in accordance with regulatory requirements and industry standards. Ensure clarity, accuracy, and consistency… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …range of tasks essential to the submission, approval, and maintenance of required regulatory documents for conducting clinical research in compliance with the ... and evaluates data and time management processes to meet compliance guidelines and data submission deadlines for regulatory...Reports for submission to the IRB, protocol sponsor, in compliance with the FDA and IRB policies.… more
- Hired by Matrix (Palo Alto, CA)
- …and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance . Performs review of promotional material for ... regulatory compliance according to country specific requirements. What You Bring:...license Applications and EU MDR technical files. Knowledge of regulatory guidance documents ( FDA , Health Canada, and… more
- Reynolds Consumer Products Inc. (Lake Forest, IL)
- …regulations pertinent to Reynolds' business and products.Maintain the internal regulatory compliance database.Prepare educational materials and presentations to ... affairs, including by providing feedback on proposed regulations.Review and analyze regulatory compliance documentation and submissions to federal agencies,… more
- DivIHN Integration Inc (Scarborough, ME)
- …existing marketing authorizations. Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations. Develops ... wide variety of complex work assignments. Maintains and ensures compliance to the appropriate quality system for the specific...and effectiveness of client Quality Management System per ISO, FDA , and other regulatory agencies. Responsible for… more
- DivIHN Integration Inc (Lake Forest, IL)
- …existing marketing authorizations. Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations. Develops ... 12 Months Description Exempt/Non Exempt: Non Exempt Years Ensures compliance to and is able to demonstrate knowledge of...and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies. Responsible for… more
- DivIHN Integration Inc (Lake Forest, IL)
- …existing marketing authorizations. Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations. Develops ... and effectiveness of Client Quality Management System per ISO, FDA , and other regulatory agencies. Responsible for...Management System per ISO, FDA , and other regulatory agencies. Responsible for exhibiting professional behavior with both… more
- Medline Industries LP (Northfield, IL)
- …life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related. Work Experience 2 years of experience ... in medical device regulatory affairs or quality assurance. Knowledge / Skills /...demonstrating the ability to perform within. Applied knowledge of FDA regulations and guidelines. Ability to evaluate information to… more
- DivIHN Integration Inc (Round Lake, IL)
- …plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System. ... corrective and preventive action is effective. Qualifications: Knowledge of cGMP and global regulatory guidelines such as EMA, FDA , and other health agencies.… more
- Fidelity TalentSource LLC (Boston, MA)
- …plus\u00A0Strong attention to detail and experience supporting a regulatory compliance program\u00A0\u00A0Strong analytical, organizational, and problem-solving ... promotes a culture of ethical conduct and commitment to compliance , regulatory and legal obligations.\u00A0 In this...for securing, trading, and supporting investments in digital assets. FDA is part of the Enterprise Services portfolio of… more
- American Honda Motor Co Inc (Torrance, CA)
- …clearance of imported merchandise containing the required data elements per the regulatory requirements and deadline. Support export compliance procedures such ... join our team to Bring the Future!Job PurposeThe Trade Compliance Department implements and coordinates compliance and...(BIS), Office of Foreign Assets Control (OFAC), DOT/NHTSA, EPA, FDA , etc Learn and use Honda's internal systems (Cost… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …yearly review of studies, completing yearly documents required by sponsor, IRB and FDA . Review case report forms. Audit regulatory binders. Ensure timely and ... studies. Ensures the requirements are met for subject enrollment and compliance from entry through follow up, investigator participation, data report submission… more
- Careerbuilder-US (San Marcos, CA)
- … to the Quality Management System (QMS) to meet customer requirements, regulatory and compliance requirements, quality standards, company goals and objectives. ... and maintenance to it is compliant to customer requirements, FDA regulations and ISO specifications. * Ensure the production...Create and maintain QMS documentation to meet the company, regulatory and compliance requirements. * Schedule, plan,… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- Job Description:Fidelity Digital Assets ( FDA ) is dedicated to building products and services that help institutions adopt digital assets and innovate within the ... of finance.\u00A0 As a Senior Business Analyst on the FDA Product Delivery team you would have the opportunity...members in the operations, client service, business development, risk, compliance , legal and technology areas. This role requires a… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …other regulatory documents (eg, IB, DSUR, PSUR, etc.) to ensure regulatory compliance .Manages and monitors nonclinical studies (GLP and non-GLP) at external ... CROs per Jazz standards and ensures that global regulatory / compliance requirements are met/exceeded.Critically reviews and edits CRO nonclinical toxicology study… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …the Environment of Care Coordinator that ensure compliance with DNV, NFPA, OSHA, FDA , EPA and other health care regulatory agencies. Is knowledgeable in the ... regulatory program designed to achieve DNV accreditation, and compliance with many other regulatory agencies to include GAEPD, DCH, CMS, DOT and other… more
- Alpha Baking (Chicago, IL)
- …quality testing results, inspection findings, and corrective actions taken, ensuring compliance with regulatory requirements and internal procedures. Assist in ... Strong understanding of food safety principles, quality management systems, and regulatory requirements (eg, FDA , GMP, HACCP). Proven leadership skills… more
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