Regulatory Affairs Project Manager Jobs in Fremont, CA | Glassdoor
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Regulatory Affairs Project Manager Jobs in Fremont, CA

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  • 2.9
    ZOLL Medical Corporation – San Jose, CA
    Est. Salary $90k-$139k
    24 days ago 24d
    for a Project Manager, Regulatory Affairs in its San Jose Division. The Project Manager is a key member of the Regulatory Affairs… President of Regulatory Affairs & Quality Assurance. The position is responsible for US and International regulatory submissions…
  • 3.7
    Bayside Solutions – Redwood City, CA
    EASY APPLY
    1 days ago 21hr
    overlooked and undertreated. The Regulatory Affairs Manager will be responsible for regulatory review of advertising and promotional… Bayside Solutions is seeking a Regulatory Affairs Manager (PRC) to be a part of our client's team in Redwood City. Our partner…
  • 3.4
    Abbott – Santa Clara, CA
    Est. Salary $105k-$143k
    8 days ago 8d
    contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to… is recognized as a discipline expert and resource in regulatory affairs. Influence/Leadership: * Develops, communicates, and builds…
  • 2.9
    Verseon – Fremont, CA
    Est. Salary $63k-$98k
    18 days ago 18d
    Location: Fremont, CA Regulatory Affairs Manager We are seeking a Regulatory Affairs Manager who is ready to help develop and… Qualifications: Bachelor’s degree or higher with 5 years of regulatory affairs experience in the pharmaceutical industry Logical and…
  • 3.8
    Stryker – Fremont, CA
    Est. Salary $117k-$162k
    4 days ago 4d
    Team. Communicates with regulatory agencies under the guidance of the Regulatory Affairs Department Manager. Plans and executes meetings… Information Under general supervision of the Regulatory Affairs Department Manager or Director Prepares complex submissions…
  • 4.1
    ZELTIQ Aesthetics – Pleasanton, CA
    Est. Salary $90k-$137k
    12 days ago 12d
    Qualifications: • BS or BA degree plus 4-6 years experience in regulatory affairs with more than 2 years in medical devices preferred. Additional… development teams, reviewing testing, protocols and project path to ensure that all regulatory requirements are identified as early as possible…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $115k-$160k
    4 days ago 4d
    accordance with corporate objectives • Represent Regulatory Affairs CMC on project teams and ensure communication of CMC information… preparation of regulatory submissions -- which requires interaction with departments outside of Regulatory Affairs -- for investigational…
  • 3.0
    Ultragenyx Pharmaceutical – Brisbane, CA
    Est. Salary $205k-$278k
    Today 11hr
    Summary: The Associate Director, Regulatory Affairs will be responsible for managing key regulatory aspects (nonclinical, clinical… successfully manage major submissions and critical projects to deadlines Proven ability to successfully interact with regulatory authorities…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $155k-$212k
    22 days ago 22d
    highly beneficial. Minimum of 7+ years of relevant Regulatory Affairs, Advertising and Promotional Materials experience in the… Promotion. Candidate to assist with additional regulatory projects as needed. Qualifications: Must…
  • 3.6
    Medtronic – Sunnyvale, CA
    Est. Salary $94k-$121k
    7 days ago 7d
    changes to existing products for impact on global regulatory affairs submissions. Manage commercial distribution of products by maintaining… RegulatoryAffairs experience is required. International Regulatory Affairs experience is required. Non-technical degree with equivalent…
  • 4.4
    AirXpanders – Palo Alto, CA
    Est. Salary $76k-$112k
    21 days ago 21d
    include: Represent Regulatory Affairs on product development project teams to ensure all regulatory requirements are met throughout… compliance with regulatory filings, review product changes for impact on regulatory filings globally, and research regulatory issues and…
  • 3.7
    Singulex – Alameda, CA
    Est. Salary $123k-$208k
    4 days ago 4d
    degree preferred or a focused degree in Regulatory Affairs. 10+ years related regulatory experience In-vitro diagnostic (reagents… leadership skills and experience in managing a department of Regulatory Affairs professionals. Further, the candidate will have extensive…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $74k-$109k
    12 days ago 12d
    representing Regulatory Affairs and foster positive and productive working relationships between project team members and regulatory agency… Prepare departmental guidelines for Regulatory Affairs and communicate new regulatory requirements across the company as appropriate…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $67k-$97k
    5 days ago 5d
    POSITION SUMMARY The Regulatory Affairs Specialist will be responsible for the preparation of regulatory submissions required… or pharmaceutical industry, preferably in the area of regulatory affairs. KNOWLEDGE, SKILLS, AND ABILITIES Current…
  • 3.5
    Relypsa Inc. – Redwood City, CA
    Est. Salary $100k-$143k
    5 days ago 5d
    Summary: The Manager, Regulatory Affairs will have broad Regulatory responsibilities and serve as the regulatory lead for designated… complete assigned projects Inform Regulatory personnel and personnel in other departments of new regulatory guidance and regulations…
  • 4.3
    Ascent Services Group – Mountain View, CA
    25 days ago 25d
    Manager of Regulatory Affairs Mountain View, CA Perm/FTE Responsible for leading regulatory affairs, post-market products… cleared or approved by the regulatory bodies, Preparation and maintenance of SOPs for Regulatory Affairs group, Working with QA…
  • 3.5
    Cardinal Health – Milpitas, CA
    Est. Salary $51k-$78k
    6 days ago 6d
    experience as a project leader with strong project management skills. Advanced degree and/or regulatory affairs certification (RAC… What Reg Affairs Manufacturing FDA contributes to Cardinal Health Regulatory Affairs Manufacturing (FDA) is responsible for…
  • 3.6
    Agilent Technologies – Santa Clara, CA
    Est. Salary $101k-$141k
    18 days ago 18d
    www.agilent.com. Regulatory Affairs ensures compliance to medical device and IVD regulations globally. The Regulatory Affairs Department… Responsibilities: • Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals of Companion…
  • 3.6
    CooperVision – Pleasanton, CA
    5 days ago 5d
    Years of experience 2-5 w/Bachelors; 0-2 w/Masters Regulatory Affairs Certification, preferred. EXPERIENCE Working… and regulatory requirements. The Global Regulatory Compliance Specialist will report directly to the Senior Manager of…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $116k-$160k
    5 days ago 5d
    Director, Regulatory Affairs (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 regulatory affairs with experience associated with global submissions.…
  • 3.2
    Gilead Sciences – Foster City, CA
    Est. Salary $115k-$160k
    4 days ago 4d
    information to project teams and senior management in a timely manner. The Manager will assist senior Regulatory Affairs personnel in local… Job Description The Manager in Regulatory Affairs, Advertising and Promotions is responsible for providing strategic and operational…
  • 3.1
    Natera – San Carlos, CA
    Est. Salary $96k-$162k
    5 days ago 5d
    is currently seeking a Manager/Associate Director of Regulatory Affairs. The Manager, Regulatory Affairs is responsible and accountable… Represents Regulatory Affairs Function as the new product development Core Team Member. Assesses regulatory pathways for…
  • 1.9
    Pharmacyclics – Sunnyvale, CA
    Est. Salary $101k-$185k
    7 days ago 7d
    Sr. Manager will also be responsible for participating and/or leading Regulatory Affairs systems implementation projects, including… • Provides regulatory operations guidance and information to Regulatory Affairs department and submission project teams. • Assists…
  • 3.4
    Abbott – Santa Clara, CA
    Est. Salary $68k-$124k
    11 days ago 11d
    contributor, the function of a Senior Regulatory Affairs 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…
  • 3.0
    Ultragenyx Pharmaceutical – Brisbane, CA
    Est. Salary $200k-$294k
    Today 11hr
    for leading the Regulatory Affairs CMC group and developing, implementing, and advising on global CMC regulatory strategies for… seeking a highly motivated VP or Executive Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast paced, dynamic…
  • 3.4
    Abbott – Santa Clara, CA
    Est. Salary $105k-$143k
    13 days ago 13d
    contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to… is recognized as a discipline expert and resource in regulatory affairs. Influence/Leadership: · Develops, communicates, and…
  • 2.7
    Agilent Technologies UK Ltd – Santa Clara, CA
    Est. Salary $74k-$109k
    7 days ago 7d
    ****. Regulatory Affairs ensures compliance to medical device and IVD regulations globally. The Regulatory Affairs Department… Responsibilities: - Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals of Companion…
  • Shockwave Medical – Fremont, CA
    Est. Salary $78k-$119k
    18 days ago 18d
    listing, and report table levels Represent Clinical Affairs at the Project Team level for individual studies, as appropriate… (SWMI) Clinical Affairs is looking for an enthusiastic, motivated candidate to be a Clinical Research Manager in our dynamic environment…
  • 3.5
    Relypsa Inc. – Redwood City, CA
    Est. Salary $151k-$205k
    25 days ago 25d
    The Associate Director, Regulatory Affairs will be responsible for performing or managing key regulatory activities for the department… Participate on Regulatory Affairs sub teams for activities related to the development of labeling for regulatory submissions.…
  • 3.2
    Gilead Sciences – Foster City, CA
    1 days ago 19hr
    CMC functional groups as well as Regulatory Affairs to plan and produce high quality regulatory submissions while meeting aggressive… minimal direction from a senior regulatory affairs professional Must have in-depth knowledge of regulatory requirements, including ICH…
  • 3.2
    Gilead Sciences, Inc. – Foster City, CA
    Est. Salary $72k-$100k
    3 days ago 3d
    meetings are chaired by a Regulatory Project Manager). -Act as a champion of the Regional CMC Regulatory viewpoint. -Work with… updates and/or regulatory position papers for consideration by the Research Project Review, Development Project Review and High…
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