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regulatory affairs in San Diego

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  1. Sr. Principal Scientist - Microbiology (Manufacturing Experience Required) at firstPRO Inc.

    Operations, Manufacturing/Materials Management, Supply Chain, Corporate and Plant Quality, Manufacturing, Regulatory Affairs, Marketing, Finance, Executive...

  2. Senior Scientist, CMC at Dart NeuroScience LLC

    Specific responsibilities will include authorship of CMC-related regulatory filings (both U.S. This person will work closely with the development team,...

  3. EMC Technician at Tuv America

    TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has an immediate openings at our San Diego, CA...

  4. Drug Safety & Pharmacovigilence Risk Management Scientist at Intercept Pharmaceuticals

    Pharmacovigilance, Risk management, medical writing, regulatory affairs, scientist. 5+ years of regulatory affairs experience, including international...

  5. Staff Scientist at Illumina, Inc.

    Experience collaborating with regulatory affairs and quality management to prepare documentation for product submissions. As a....

    Ads
    1. Director, Quality Administration

      JOB SUMMARY: In conjunction with the Chief Quality & Safety Officer, directs the overall administration of quality & improvement resources in the organization. Responsibilities include the monitoring of clinical services processes & outcomes to ensure, at a minimum, compliance with regulatory quality assurance standards & requirements. Assess the need for & implement interventions to ...

    2. Sr Regulatory Affairs Specialist

      Our Clent: Specializas in the design and manufacturing of high performance surgical knifes and wound closure products.POSITION SUMMARYPrepares regulatory submissions and regstration documentation. Provides quality and timely regulatory support to obtain marketing clearance/approval for new products; devices/drug-device combinations. Mantains marketability of existing products.PRIMARY ...

    3. V&V Engineer

      Job Description:We are seeking an experienced Software V & V Engineer for our Software V&V team.  In this hands-on software testing role the individual will work on projects related to testing of software for highly complex medical devices/instrumentation.DESCRIPTION OF POSITION RESPONSIBILITIES:Plans, writes test cases, test reports, and tests software and hardware requirements.Troubleshoots ...

    4. Sr. Marketing Manager

      Our fabulous San Diego client needs a Sr Marketing Manager to join their team. This is a very senior level role, with a strong emphasis on branding.The right candidate will have: 1. Downstream marketing experience (in medical device and FDA, preferred)2. Seven years of experience in marketing 3. FDA regulated experience in Class 3 or Class 2 (less ideally) The Senior Manager, Brand Marketing ...

    5. Companion Diagnostic Development Director - San Diego, CA

      Newly founded biotech company seeking individual with proven success leading efforts for companion diagnostic or clinical trials in collaboration with oncology therapeutic trials. Functions: *** Create clinical trial protocols, case report forms, study reports and clinical data listing for trials. *** Oversee development and approval of biomarkers for drug efficacy and patient selection ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    6. Regulatory Lead (430488)

      **ONLY LOCAL, SOUTHERN CALIFORNIA APPLICANTS PLEASE** Job Description Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met. Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development program. Proactively identify project issues and ...

    7. Manager Medicare Compliance

      Location This position is located in Kearny Mesa, San Diego Hours 8-hour shift; weekends as needed Required Skills and Qualifications Bachelor's degree in related field 3 to 5 years' of compliance experience within the health care industry Working knowledge of Medicare Advantage regulations, resources and processes Experience designing, conducting and monitoring compliance ...

    8. FDA  QA Regulatory Affairs Specialist

      FDA Quality & Regulatory Specialist Job description: We are looking for a QA/RA specialist to our team to ensure our quality system and FDA requirements for medical devices, class I, IVD and ASR. The incumbent will responsible for labeling Products to meet FDA and iso13485 requirements. Essential Functions: Document Control and Change Control Conduct internal audits New Product ...

    9. Senior Member of Technical Staff – Systems Engineering (Direct Hire)

      TechHive is a US based company, headquartered in San Diego, California, focused on connecting high-tech companies with skilled professionals. TechHive is founded by technology professionals who are currently working in the industry and understand our client's daily challenges. We currently have an exciting opportunity for a Senior Systems Engineer – Medical Devices The Senior Systems ...

    10. Medical Affairs Director - Hodgkin's Disease & Non Hodgkin's Lymphoma

      Excellent opportunity for experienced Medical Affairs or Clinical Development director to join a growing bio-pharmaceutical company and own all activities under the Hematology/Oncology umbrella with a focus on developing strategies for launching new drugs. Shall: *** Lead all major aspects of Medical Affairs for novel therapeutics from pre-launch through post-launch activities. *** ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    11. Project Coordinator Compliance

      Location This position is located in Kearny Mesa, San Diego CountyHours 8-hour shift: 8:00 am - 5:00 pm, weekends as needed.Required Skills and Qualifications Undergraduate degree in health care, business, law or related field Knowledge of state and federal laws and regulations applicable to health plans and health insurance, and Medicare Advantage plans Knowledge of health plan operations ...

    12. Customer Advocacy RN

      This position is responsible for assisting with the triaging of customer experiences or questions received directly from customers or those escalated through the organization. Responsible for the completion of all tasks associated with management of complaint handling including reviewing, investigating, resolving, replying and trend reporting in conjunction with failure investigation team. ...

      1. Sr Scientist at Illumina, Inc.

        Experience collaborating with regulatory affairs and quality management to prepare documentation for product submissions. As a....

      2. Scientist 2 at Illumina, Inc.

        Experienced in collaborating with regulatory affairs and quality management to prepare documentation for product submission to various globally regulated...

      3. Medical Writer I at Planet Pharma

        Medical writing, regulatory affairs, clinical research, engineering). Ph.D/Pharm D plus 1 to 2 years of related medical device/drug industry experience (e.g....

      4. QA Associate at Sterling Hoffman Life Sciences

        Interface with production, QA/QC, R&D and regulatory affairs to obtain required information and prepare related domestic and international submissions....

      5. Regulatory Affairs Specialist at Sterling Hoffman Life Sciences

        Preference will be given to people with recent experience in regulatory affairs. Provide regulatory reviews of customer complaints and define regulatory report...