- Mindlance (Charlotte, NC)
- Job Title: Regulatory Specialist (FR Y-14Q) Location: NY, NJ, MN, TX, NC, AZ, CA (3 days onsite, 2 days remote) Duration: 12+ months Required Qualifications: 7+ ... Lead Business Execution Consultant, as part of the Finance & Risk Regulatory reporting function within the Commercial Banking. Candidates will be interested in… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …of improving the health of our communities. About the Role:Job SummaryThe Research Regulatory Specialist performs a wide range of tasks essential to the ... submission, approval, and maintenance of required regulatory documents for conducting clinical research in compliance with the Federal Food and Drug Administration… more
- A-Line Staffing Solutions (Alameda, CA)
- A-Line Staffing is now hiring Regulatory Compliance Specialist in Alameda, CA. The Regulatory Compliance Specialist would be working for a Fortune 500 ... / 40+ hours per week. If you are interested in this Regulatory Compliance Specialist position, please contact Brady Czape at ###@alinestaffing.com or ### … more
- Sunrise Systems Inc (Andover, MA)
- Job Title: Regulatory Affairs Specialist - Labeling - Junior Job ID: 24-02349 Location: Andover, MA Duration: 12 Months contract on W2 Description: Role Overview ... Include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc. Through coordination/collaboration with direct… more
- Aequor (TX)
- …NBL Manager in Lifecycle Change Management projects. Pro-actively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of ... regulatory support, review and approval of applications with the...the delivery of internal training and guidance to Site Regulatory Assessors on EU Medical Device Significant Change Notification… more
- Spectraforce Technologies Inc (Athens, GA)
- Job Title: Specialist , US Regulatory Affairs Operations (Part-Time) Duration: 18 Months Location: St. Joseph, MO or Athens, GA Schedule: 20 hours per week; ... 2-3 days a week. Duties: With minimum guidance, prepare high-quality US regulatory submissions required by local and federal agencies to maintain Company products… more
- Spectraforce Technologies Inc (Bridgewater, NJ)
- Job title: CMC Regulatory Technical Writer II Location: Bridgewater, NJ, Hybrid Duration: 1 year SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri Pay Rate starts: $47/ HOUR ... have experience with CTD (Common Technical Document) modules. Will complete regulatory submissions, compliance, and amendments. Expert in Microsoft Office (Word,… more
- Hired by Matrix (Palo Alto, CA)
- …medtech company? If so, our client is hiring a SrRegulatory Affairs Specialist !What You'll Do: Perform the coordination and preparation of regulatory ... submissions for brachytherapy devices and software devices according to regulatory requirements. Identifies, analyzes and implements country specific requirements… more
- Nesco Resource (Plymouth, MN)
- …events globally. This may include: complaint initial triage, submitting regulatory reports in accordance with applicable regulations, referring potential safety ... for evaluating complaints from patient safety perspective and completing regulatory reporting decisions per reporting requirements globally. Responsible for creating… 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 /...Knowledge / Skills / Abilities Understanding of the current Regulatory environment and demonstrating the ability to perform within.… more
- Merck & Co. (Millsboro, DE)
- …tests, and review and release of antigen and seed batches. The QC associate specialist must adhere to regulatory and site policies and procedures governing the ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- American Honda Motor Co Inc (Marysville, OH)
- …reporting, and gaining consensus from manufacturing departments. Problems are both safety/ regulatory and commercial quality control items. Ability to work well with ... cross functional departments.Lead quality new model and mass production start-up verification activity related to Safety, Quality and Delivery. Prioritize and direct group efforts based on business needs.Investigate and help develop countermeasures to resolve… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist , Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, organizes, monitors,… more
- Creative Financial Staffing (Pittsburgh, PA)
- …showcasing your expertise in managing billing processes as a Medical Billing Specialist . Regulatory Knowledge: Demonstrated understanding of EOB (Explanation of ... MEDICAL BILLING SPECIALIST ABOUT THE COMPANY: Are you seeking a...seeking a fulfilling career opportunity as a Medical Billing Specialist that not only allows you to excel professionally… more
- Merck & Co. (Rahway, NJ)
- …dedicated colleagues while developing and expanding your career.The Senior Trial Initiation Specialist in Global Site Budgets and Payments will be responsible for ... and presentation skills.Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines which includes knowledge of Standard of Care/Routine Care and… more
- Merck & Co. (Rahway, NJ)
- …CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other ... and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines.- Assisting with developing and… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... are driving change. Are you ready to make a difference? The Position The Specialist , API Manufacturing works in Novo Nordisk's Boulder, Colorado Pilot Plant and is… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist , Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively support, participate and embrace an empowered team culture… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role ... Overview We are actively seeking a proficient SAP Master Data Sr. Specialist with a specific focus on Materials orchestration throughout the End-to-End Manufacturing… more
- Merck & Co. (North Wales, PA)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... data governance reviewsThe Global Clinical Data Standards (GCDS) Data Standards Specialist may contribute to the definition and maintenance of business processes… more
