Senior Regulatory Affairs Manager Jobs in Santa Clara, CA | Glassdoor
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Senior Regulatory Affairs Manager Jobs in Santa Clara, CA

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  • 3.6
    Agilent Technologies – Santa Clara, CA
    Est. Salary $103k-$143k
    19 days ago 19d
    in development or currently marketed globally. The SeniorRegulatoryAffairs Specialist will collaborate with Agilent international… www.agilent.com. RegulatoryAffairs ensures compliance to medical device and IVD regulations globally. The RegulatoryAffairs Department…
  • 3.6
    Medtronic – Sunnyvale, CA
    Est. Salary $93k-$123k
    7 days ago 7d
    changes to existing products for impact on global regulatoryaffairs submissions. Manage commercial distribution of products by maintaining… RegulatoryAffairs experience is required. International RegulatoryAffairs experience is required. Non-technical degree with equivalent…
  • 4.5
    AirXpanders – Palo Alto, CA
    Est. Salary $76k-$113k
    21 days ago 21d
    include: Represent RegulatoryAffairs on product development project teams to ensure all regulatory requirements are met throughout… and dissemination of regulatory information to production, QA, QC and R&D departments and senior management as required. QUALIFICATIONS…
  • 4.4
    Ascent Services Group – Palo Alto, CA
    12 days ago 12d
    SeniorManagerRegulatoryAffairs Palo Alto, CA or Philadelphia, PA Permanent Responsibilities: Participate as… to regulations and applicable guidelines for all regulatory submissions Manage timelines to ensure approvals are timely and development…
  • 3.0
    Absolute Opportunities – Santa Clara, CA
    Est. Salary $90k-$143k
    11 days ago 11d
    SeniorRegulatoryAffairs Specialist - RT Santa Clara, California 95052 SeniorRegulatoryAffairs Specialist -… , solid project / organizational skills. As a SeniorRegulatoryAffairs Specialist, your job responsibilities will include…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $133k-$177k
    NEW
    Description: The Senior Project Manager of Marketing Operations supports the commercial organization and ensures flawless… partners/stakeholders: Sales, Marketing, Market Access, Medical Affairs, etc. Follow all laws, regulations and policies that…
  • 3.5
    Abbott – Santa Clara, CA
    Est. Salary $69k-$124k
    12 days ago 12d
    contributor, the function of a SeniorRegulatoryAffairs Specialist is to provide support for the regulatory department to ensure efficient… experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations…
  • Alkahest, Inc. – San Carlos, CA
    4 days ago 4d
    Alkahest is looking for a Director / Sr. Director of RegulatoryAffairs who can apply his or her knowledge of global regulations… . Responsibilities: Develop regulatory strategies in collaboration with senior management and by analysis of guidances…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $156k-$210k
    7 days ago 7d
    SUMMARY The Director, RegulatoryAffairs leads, plans, coordinates, conducts and reports on regulatory registration programs.… strategies for a range of complex regulatoryaffairs programs with emphasis on requirements and submissions associated with IVD systems…
  • 3.9
    Planet Pharma – Palo Alto, CA
    Est. Salary $90k-$131k
    12 days ago 12d
    BH36674 Category: RegulatoryAffairs Industry: Biotechnology The SeniorManager, Regulatory Strategy will be responsible… to regulations and applicable guidelines for all regulatory submissions Manage timelines to ensure approvals are timely and development…
  • 3.5
    Abbott – Santa Clara, CA
    Est. Salary $106k-$144k
    14 days ago 14d
    contributor, the function of a RegulatoryAffairs Project Manager is to combine knowledge of scientific, regulatory and business issues to… is recognized as a discipline expert and resource in regulatoryaffairs. Influence/Leadership: · Develops, communicates, and…
  • EBR Systems, Inc. – Sunnyvale, CA
    EASY APPLY
    28 days ago 28d
    Assists clinical affairs management in creation and/or submission of clinical study reports, regulatory submissions, publications… in-house (Sunnyvale, CA) and will support the Sr. Manager of Clinical Affairs with the management of clinical study materials/documentation…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $99k-$144k
    4 days ago 4d
    collaboration with clinical sites, Clinical Operations, RegulatoryAffairs and other stakeholders to ensure compliance with GCPs… conducted in accordance with the audit plan, GCP guidelines and regulatory requirements • Lead and co-audit US and international sites…
  • 3.9
    Stryker Corporation – San Jose, CA
    Est. Salary $63k-$101k
    6 days ago 6d
    degree; 1 year of experience with Master's degree. RegulatoryAffairs Certification preferred. Must be able to analyze and… and assess them for regulatory reporting Submit initial and follow-up reports to device related regulatory agencies as appropriate…
  • 2.9
    Apex Life Sciences – San Jose, CA
    Est. Salary $75k-$131k
    30+ days ago 30d+
    SeniorRegulatoryAffairs Analyst Ensures regulatory compliance by completing the appropriate filings and documentation pertaining… with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $142k-$189k
    28 days ago 28d
    departments including marketing, sales operations, legal, regulatory, medical affairs, payer/access, corporate compliance, and IT… projects through the internal legal, regulatory, and medical review process Manage program budgets and metrics to ensure…
  • 4.6
    Sequoia – San Jose, CA
    EASY APPLY
    Est. Salary $72k-$101k
    NEW
    . Our team manages projects in automation, facility design, engineering, manufacturing, quality, regulatoryaffairs and validation… Sequoia is seeking a Senior Validation Engineer who will contribute to Equipment and Process Validation. The Senior Validation Engineer…
  • 4.4
    Ascent Services Group – Pleasanton, CA
    27 days ago 27d
    Senior Director Global RegulatoryAffairs CMC East San Francisco Bay Area Permanent Responsibilities: Work closely… of CMC regulatoryaffairs experience is preferable, or BS/MS in life sciences with 10+ years of CMC regulatoryaffairs experience…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $74k-$109k
    13 days ago 13d
    representing RegulatoryAffairs and foster positive and productive working relationships between project team members and regulatory agency… Prepare departmental guidelines for RegulatoryAffairs and communicate new regulatory requirements across the company as appropriate…
  • 4.0
    Apple – Santa Clara, CA
    13 days ago 13d
    work with Apple business, engineering, legal, and government-affairs teams to assess the likely impacts of draft and final regulations… You will help coordinate Apple’s positions on proposed regulatory requirements and, marshal the facts and arguments that regulators…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $96k-$143k
    19 days ago 19d
    required. Work is performed under limited direction of a seniorRegulatoryAffairs professional. [1] https://regulatoryaffairs-careers.gilead.com… INDs and NDAs. Under the general direction of a seniorRegulatoryAffairs professional, preparing investigational, new drug…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $115k-$155k
    5 days ago 5d
    Director, RegulatoryAffairs (Device) will be responsible for managing all regulatory aspects for US and International regulatory submissions… IDEs, 510(k)s. and/or PMAs required. At least 3 years of regulatoryaffairs with experience associated with global submissions.…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $110k-$157k
    5 days ago 5d
    Biometrics, RegulatoryAffairs, etc.), to ensure effective delivery of the assigned project milestones Organizes and manages internal… conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work Instructions. Key…
  • 3.5
    Genomic Health, Inc. – Redwood City, CA
    Est. Salary $264k-$418k
    7 days ago 7d
    The Senior Director will be responsible for the U.S. strategic management and direction of medical affairs activities supporting… . Reporting to the Vice President, Global Medical Affairs, this senior level position requires professionals with established…
  • 3.9
    Sonexus Health – Milpitas, CA
    NEW
    and Pre-Clinical programs and Clinical Affairs. May perform as a scribe, back room manager, request administrator or other critical… programs, including but not limited to, audits of the clinical affairs department, audits of clinical trial program suppliers, Principal…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $117k-$161k
    26 days ago 26d
    to project teams and senior management in a timely manner. The Manager will assist seniorRegulatoryAffairs personnel in local… from a seniorRegulatoryAffairs professional. The position will be recognized as a knowledgeable resource for regulatory advice…
  • 3.2
    Cepheid – Sunnyvale, CA
    NEW
    analytical sections for regulatory submissions. Interact with RegulatoryAffairs and FDA or other regulatory and global (e.g. WHO… JOB SUMMARY: Administer and supervise the Clinical Affairs department and external clinical review organization to monitor…
  • 3.5
    Cardinal Health – Milpitas, CA
    NEW
    and Pre-Clinical programs and Clinical Affairs. May perform as a scribe, back room manager, request administrator or other critical… programs, including but not limited to, audits of the clinical affairs department, audits of clinical trial program suppliers, Principal…
  • 3.6
    CooperVision – Pleasanton, CA
    6 days ago 6d
    and regulatory requirements. The Global Regulatory Compliance Specialist will report directly to the SeniorManager of… Years of experience 2-5 w/Bachelors; 0-2 w/Masters RegulatoryAffairs Certification, preferred. EXPERIENCE Working…
  • 3.6
    Mercedes Benz – Sunnyvale, CA
    6 days ago 6d
    brings hydrogen vehicles to the road. The Testing and RegulatoryAffairs Division in Ann Arbor, MI and the Advanced Vehicle Design… different lines of business and/or technologies Proven ability to manage conflicting priorities in a fast-paced environment Ability…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $112k-$147k
    NEW
    communication among various RegulatoryAffairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising… trends in RegulatoryAffairs. Ten to twelve years of relevant experience are required; experience in both RegulatoryAffairs and Project…
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