- Novo Nordisk (Princeton, NJ)
- …projects and roles. Essential Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain ... health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support… more
- Leidos (Reston, VA)
- …! **The Leidos Health Solutions Group is seeking a Portfolio Director supporting the FDA , located in the DMV area.** This position will report to the Health ... Solutions Division Manager , Vice President. The ideal candidate will provide oversight...government health programs + Minimum 5 years experience with FDA programs. + Experience developing solutions and managing programs… more
- RWJBarnabas Health (New Brunswick, NJ)
- … with responding to/correcting medical equipment recalls/device alerts from manufactures and/or FDA + Assists Manager in giving medical equipment in-services to ... + Assists with new equipment installations as assigned. + Assist Manager in maintaining and fulfilling the department/organization s regulatory requirements and… more
- RWJBarnabas Health (West Orange, NJ)
- … with responding to/correcting medical equipment recalls/device alerts from manufactures and/or FDA + Assists Manager in giving medical equipment in-services to ... equipment. Assists with new equipment installations as assigned. + Assist Manager in maintaining and fulfilling the department/organization s regulatory requirements… more
- RWJBarnabas Health (Livingston, NJ)
- … with responding to/correcting medical equipment recalls/device alerts from manufactures and/or FDA + Assists Manager in giving medical equipment in-services to ... equipment with competence appropriate to job proficiency level. + Assist Manager in maintaining and fulfilling the department/organization s regulatory requirements… more
- Catalent Pharma Solutions (Bloomington, IN)
- …meet the quality standards and requirements of company policies and FDA regulations. **The Process Validation Manager 's responsibilities include managing ... experience, required + Possesses a strong understanding of guidance documents from FDA , EMA, PDA, ISPE, and other industry organizations + Understands validation… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Manager , Manufacturing** **Summary:** _Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. ... Technology Corridor, top universities, and government agencies._ _The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP… more
- MyFlorida (Tallahassee, FL)
- …as necessary or required. + Maintains Continuing Education Units, Certified Food Manager Certification, FDA standardization and Florida driver's license. + ... Maintains state issued equipment in proper working condition. + Participates in meetings and training sessions as required. + Provides a high standard of customer service. + Performs other work as required. Knowledge, Skills, and Abilities + Knowledge of laws… more
- University of Colorado (Aurora, CO)
- IND/IDE Office Program Manager - 34555 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: Clinical Research and ... Operations Services** **Job Title: IND/IDE Office Program Manager ** **Position #: 797456 - Requisition #: 34555** **Job...the IND/IDE program for projects requiring submissions to the FDA . + Monitors tools and processes for tracking performance… more
- System One (Lakewood, CO)
- …to operating policies where appropriate + Serves as Management Representative for FDA responsibilities and holds plant manager accountable for role as ... standards (including but not limited to ISO 13485, ISO 14971, MDD, CMDR, FDA Quality System Regulations). + Extensive knowledge of US and international medical… more
- TestPros (Silver Spring, MD)
- …Public Trust Clearance Job Summary: We are seeking an experienced Quality Assurance (QA) Manager to lead our QA efforts in responding to an FDA project. ... candidate will have a strong background in regulatory compliance, particularly with FDA regulations, and will ensure that all deliverables meet the highest quality… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57668 **Who we are** ... **The opportunity** Teva Pharmaceuticals USA, Inc. is seeking a Regulatory Affairs Manager (Parsippany, NJ) to write, review and compile documentation and data… more
- Philips (Chicago, IL)
- The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' Disease ... extend in proactive, strategic relationships with external stakeholders (Notified Bodies, FDA , Competent Authorities, and other Regulatory bodies) to ensure that… more
- Alaka'ina Foundation Family of Companies (Silver Spring, MD)
- …to Program Manager regarding status of video projects. o Collaborate with Program Manager to provide updates to FDA OMHHE team. + Other duties as assigned ... Video Communications Manager (Part-Time) Location MD - Silver Spring Job...develop video concepts and story boards. + Collaborate with FDA OMHHE team and Po`okela team to draft scripts… more
- ThermoFisher Scientific (Portage, MI)
- …Responsible for maintenance and improvement of the Quality System in compliance with FDA Medical Device Quality System Regulations (QSR) and ISO 13485 for the US ... requirements. Advise management and personnel in order to assure compliance with FDA regulations and cGMP. Recommend remedial actions, and resolve internal issues… more
- Keurig Dr Pepper (Columbus, OH)
- The Regional Quality Manager for DSD is responsible for providing Corporate Quality support to our DSD region for Cold Beverage Manufacturing locations - they will ... FSMA, six sigma Quality performance and compliance to all FDA , EPA and OSHA regulations and GFSI requirements. Expect...operating in compliance with KDP Policy & Procedures, FSMA, FDA GMP, and GFSI guidelines. + Support site incident… more
- AbbVie (Irvine, CA)
- …Follow Allergan Aesthetics on LinkedIn. Job Description Description The Sr Manager Regulatory Affairs represents US regulatory affairs for device development ... appropriately and submitted on time. Directs communication and interactions with FDA , as primary contact for the related projects. Utilizing detailed, in-depth… more
- Food and Drug Administration (Silver Spring, MD)
- Summary This position is located within the Food and Drug Administration ( FDA ), Center for Drug Evaluation and Research (CDER), Office of Surveillance & Epidemiology ... decisions. Requirements Conditions of Employment Qualifications The position of Project Manager falls within the 0301 occupational series. To qualify for this… more
- BioFire Diagnostics, LLC. (Durham, NC)
- Position Summary: The QC Microbiology/EM Laboratory Manager provides direct oversight and guidance in the Quality Control Microbiology and Environmental Monitoring ... (eg, QSR and ISO9001/ISO13485). This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. QC Microbiology/EM… more
- Amneal Pharmaceuticals (Brookhaven, NY)
- Description: The Manager , Regulatory Compliance, assembles a team for site wise and/or cross departmental discussions, oversees investigation, and completes Field ... warrant notification to The Food and Drug Administration. The Manager , Regulatory Compliance is responsible for leading activities for...Functions: + Will be the contact person for the FDA and other regulatory agencies in regard to Field… more
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