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    1. Associate, Regulatory Affairs at Intercept Pharmaceuticals

      Regulatory affairs, pharma, biotech, associate, eCTD. 1 to 2 years of regulatory affairs relevant experience. Assumes other relevant assignments as directed by...

    2. Associate Director, Drug & Safety Pharmacovigilance at Intercept Pharmaceuticals

      Interact with company departments including, Clinical Operations, Regulatory Affairs, Quality Assurance, CMC and Project Management in support of drug...

    3. Project Coordinator Compliance at Sharp HealthCare

      The Legislative and Regulatory Affairs Department is responsible for ensuring Sharp Health Plan's compliance with state and federal laws and regulations....

    4. Director, Program Management at Intercept Pharmaceuticals

      Partner with the core team members and Regulatory Affairs to complete regulatory submissions. Strong understanding of drug development processes from strategic...

    5. Director Program Management at Klein Hersh International

      Partner with the core team members and Regulatory Affairs to complete regulatory submissions. Strong understanding of drug development processes from strategic...

    Ads
    1. 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 ...

    2. 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 ...

    3. 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

    4. 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 ...

    5. 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. ...

    6. Sr. Manager, Statistical Programming

      Job Description:   Sr. Manager, SAS/Statistical Programming will be responsible for directing all aspects of the management and development of the SAS/Statistical Programming team.   Duties &Responsibilities: Oversee and evaluate the design, development, modification, and evaluation process of systems and procedures for SAS/statistical programming and data analysis. Oversee SAS ...

    7. Senior Regulatory Engineer

      General Summary: This position is a member of the engineering department. The Senior Regulatory Compliance Engineer provides technical leadership on regulatory affairs and serves as a technical resource on hardware and software development teams during product development. Essential Functions: •Responsible for obtaining and maintaining regulatory approvals for new and existing products. ...

    8. Director Regulatory Affairs Oncology US/Canada hh

      Director Regulatory Affairs, US/Canada Chicago, Ill Superior Compensation and Benefits Full Relocation Paid   Therapeutic Areas: (2) Oncology, (1) Immunology Location: Chicago Area PRIMARY JOB FUNCTION: Candidate will be responsible for contributing to and implementing strategies to support assigned projects within Therapeutic Area. CORE JOB RESPONSIBILITIES: • Review, compile, and ...

    9. Regulatory Intern

      POSITION DESCRIPTION The role of the Regulatory Intern is two-fold; 1) The collection, interpretation and documentation of appropriate regulatory information for the updating and maintenance of the FOG law database and 2) the sharing and reporting of information to support LES Team Members’ work. The role will require contacting the appropriate regulatory agencies and sharing of information ...

    10. QA  Regulatory Affairs Specialist

      QA / Regulatory Affairs Specialist This Position pays Market + Full Benefits Description Job Summary: This QA/RA Specialist is responsible for maintaining and ensuring that the company quality system meets FDA requirements for class I medical devices (IVD and ASR). The QA/RA Specialist is also responsible for ensuring that products and their labeling meet all regulatory requirements ...

    11. Regulatory Affairs Manager

      Job Description Summary: The Regulatory Affairs Manager is responsible for supporting our client in their ability to market its products world-wide throughout the development life cycle by planning and coordinating regulatory submission and activities from pre-submission to approvals. Job Responsibilities Prepare regulatory filings, technical files and design dossier submissions and ...

    12. QA Regulatory Affairs Specialist

      Description This position is in the Mira Mesa area of San Diego, Ca. Job Summary: QA Regulatory Affairs Specialist Contract to Perm position: Market Rate This QA/RA Specialist is responsible for maintaining and ensuring that the company quality system meets FDA requirements for class I medical devices (IVD and ASR). The QA/RA Specialist is also responsible for ensuring that products and ...