Job Type
Date Posted
Salary Range
Distance

Regulatory Affairs Manager - Labeling Jobs in Santa Clara, CA

46 Jobs

  • 3.5
    Abbott – Santa Clara, CA
    $67k-$97k(Glassdoor est.)
    NEW
    contributor, the function of a RegulatoryAffairs Specialist is to provide support for the regulatory department to ensure efficient… preferred. Certification is a plus (such as RAC from the RegulatoryAffairs Professionals Society.) 2-3 years’ experience in a regulated…
  • 3.5
    Abbott – Santa Clara, CA
    $68k-$122k(Glassdoor est.)
    NEW
    contributor, the function of a Senior RegulatoryAffairs 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…
  • 3.5
    Abbott – Sunnyvale, CA
    $123k-$180k(Glassdoor est.)
    NEW
    direction of the RegulatoryAffairs Associate Director. Supports project teams to obtain worldwide regulatory approval or clearance… as a mentor for RegulatoryAffairs Coordinators, Associates, and Assistants. 2) Develop global regulatory strategies for new…
  • 3.5
    Abbott – Sunnyvale, CA
    $95k-$145k(Glassdoor est.)
    NEW
    the direction fo the RegulatoryAffairsManager. Supports project teams to obtain worldwide regulatory approval or clearance… Serve as a mentor for RegulatoryAffairs Coordinators, Associates, and Assistants. 2) Develop global regulatory strategies for new…
  • 2.0
    Pharmacyclics – Sunnyvale, CA
    $161k-$217k(Glassdoor est.)
    24 days ago 24d
    highly beneficial. · Minimum of 7+ years of relevant RegulatoryAffairs, Advertising and Promotional Materials experience in the… and US labeling, prior experience in oncology or hematology drugs strongly preferred. · Experience in the regulatory review…
  • 4.0
    Johnson & Johnson – Milpitas, CA
    $180k-$241k(Glassdoor est.)
    NEW
    resource in regulatoryaffairs. Comments on changing regulations and guidance. Providing executive management with regulatory metrics… years of experience in regulatory preferred. RAC certification from the RegulatoryAffairs Professionals Society a…
  • 3.6
    Abbott Laboratories – Santa Clara, CA
    $84k-$116k(Glassdoor est.)
    24 days ago 24d
    contributor, the function of a RegulatoryAffairs Specialist is to provide support for the regulatory department to ensure efficient… preferred. Certification is a plus (such as RAC from the RegulatoryAffairs Professionals Society.) 2-3 years' experience in a regulated…
  • 4.7
    23andMe, Inc. – Mountain View, CA
    $98k-$137k(Glassdoor est.)
    8 days ago 8d
    As a key member of RegulatoryAffairs, this role will focus primarily on Post-Market Advertising, Labeling and Promotion. You… company policies Review labeling and promotional documents for accuracy and adherence to regulatory requirements, while ensuring…
  • 4.7
    Shockwave Medical – Fremont, CA
    EASY APPLY
    HOT
    conformance with applicable regulatory requirements to meet business objectives. The Director of Clinical Affairs will establish processes… The Director of Clinical Affairs will play a key leadership role for the Company’s Clinical Affairs including study preparation…
  • AMO Development, LLC – Milpitas, CA
    NEW
    resource in regulatoryaffairs. Comments on changing regulations and guidance. Providing executive management with regulatory metrics… years of experience in regulatory preferred. RAC certification from the RegulatoryAffairs Professionals Society a…
  • 3.3
    BD – San Jose, CA
    $100k-$135k(Glassdoor est.)
    NEW
    negotiations with regulatory agencies on premarket submission requirements, formats, labeling claims, etc. Organizes and manages (with oversight… The Sr. RegulatoryAffairs Specialist will independently plan, coordinate, conduct, and report on BD Biosciences Regulatory Affairs…
  • 5.0
    Intersect ENT, Inc. – Menlo Park, CA
    $88k-$125k(Glassdoor est.)
    5 days ago 5d
    Responsible for working closely with the Director, RegulatoryAffairs todevelop regulatory strategies for US and international submissions… and labeling changes. Represent RA functional area in the review and approval of Change Orders (CO). Provide regulatory guidance…
  • 2.0
    Pharmacyclics – Sunnyvale, CA
    $91k-$167k(Glassdoor est.)
    16 days ago 16d
    development or medical affairs very beneficial. Minimum of 3-5+ years of relevant RegulatoryAffairs, Advertising and Promotional… and US labeling, prior experience in oncology or hematology drugs strongly preferred. Experience in the regulatory review…
  • 2.8
    Excelitas Technologies – Fremont, CA
    $125k-$180k(Glassdoor est.)
    15 days ago 15d
    reports directly to Corporate Senior Director of Global RegulatoryAffairs and Compliance. RESPONSIBILITIES: Provide guidance… evaluation and testing and CE mark requirements including product labeling and IFUs. Where necessary, work with and evaluate the performance…
  • 5.0
    Intersect ENT – Menlo Park, CA
    $67k-$105k(Glassdoor est.)
    10 days ago 10d
    EXPERIENCE REQUIREMENTS: Minimum five years of regulatoryaffairs experience in the pharmaceutical and or medical device… Orders (CO). Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials…
  • 3.6
    Abbott Laboratories – Santa Clara, CA
    $84k-$146k(Glassdoor est.)
    30+ days ago 30d+
    contributor, the function of a Senior RegulatoryAffairs 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…
  • 3.3
    Thermo Fisher Scientific – San Jose, CA
    $73k-$100k(Glassdoor est.)
    9 days ago 9d
    The RegulatoryAffairs Specialist III is responsible for providing technical support to the RegulatoryAffairsManager in order… development of best practices for RegulatoryAffairs processes. Reviews and approves proposed labeling, packaging, advertising and…
  • 3.2
    Cepheid – Sunnyvale, CA
    $84k-$122k(Glassdoor est.)
    21 days ago 21d
    MANAGER, International RegulatoryAffairs The Manager, International RegulatoryAffairs will prepare the regulatory submissions… required. Participate in international regulatory intelligence groups and represent RegulatoryAffairs on the product life-cycle management…
  • 4.7
    23andMe, Inc. – Mountain View, CA
    $74k-$108k(Glassdoor est.)
    18 days ago 18d
    for RegulatoryAffairs and in support of the quality system Manageregulatory documentation Supports ad hoc regulatory activities… What youll do Our new RegulatoryAffairs Compliance Analyst is an integral member of the RegulatoryAffairs team. In this role,…
  • 3.0
    Absolute Opportunities – Santa Clara, CA
    $89k-$142k(Glassdoor est.)
    15 days ago 15d
    Senior RegulatoryAffairs Specialist - RT Santa Clara, California 95052 Senior RegulatoryAffairs Specialist - RT IDEAL… and laws Review labeling and labels for compliance with regulatory requirements Provide the regulatory reviews of customer…
  • 4.0
    Stryker – Fremont, CA
    $88k-$136k(Glassdoor est.)
    23 days ago 23d
    International RegulatoryAffairsManager Group MedSurg and Neurotech Division Neurovascular Business Function Regulatory Affairs… and Regulatory matters and in effective business partnering with Marketing, R&D, and Clinical. Provide regulatoryaffairs training…
  • 3.5
    Allergan – Pleasanton, CA
    $151k-$213k(Glassdoor est.)
    5 days ago 5d
    Description The RegulatoryAffairsManager will be a member of the Zeltiq, an Allergan Affliate, regulatoryaffairs team located… countries) Reviews proposed product changes, labels and labeling material for regulatory impact Determines governmental regulations…
  • 2.9
    Relypsa Inc. – Redwood City, CA
    $136k-$182k(Glassdoor est.)
    NEW
    Participate on RegulatoryAffairs sub teams for activities related to the development of labeling for regulatory submissions.… The Associate Director, RegulatoryAffairs will be responsible for performing or managing key regulatory activities for the department…
  • 4.0
    Stryker – Fremont, CA
    $110k-$152k(Glassdoor est.)
    8 days ago 8d
    Team. Communicates with regulatory agencies under the guidance of the RegulatoryAffairs Department Manager. Plans and executes meetings… Information Under general supervision of the RegulatoryAffairs Department Manager or Director Prepares complex submissions…
  • 4.0
    Stryker – Fremont, CA
    $86k-$122k(Glassdoor est.)
    10 days ago 10d
    Senior RegulatoryAffairs Specialist Group MedSurg and Neurotech Division Neurovascular Business Function Regulatory Affairs… result, the Regulatory team is large and covers a broad swath of geographies and products. The NV RegulatoryAffairs organization…
  • 4.0
    Stryker – Fremont, CA
    $101k-$139k(Glassdoor est.)
    4 days ago 4d
    result, the Regulatory team is large and covers a broad swath of geographies and products. The NV RegulatoryAffairs organization… 400 submissions per year across the globe. The NV RegulatoryAffairs organization is leading the charge for stroke clinical…
  • 4.2
    Clorox – Pleasanton, CA
    $81k-$114k(Glassdoor est.)
    NEW
    Corporate Quality, Marketing, Product Supply and Government Affairs. Support a culture of curiosity, collaboration, critical… : As a Regulatory Specialist in the Global Stewardship (GS) function you will work within a team of regulatory professionals…
  • 4.0
    Stryker Corporation – Fremont, CA
    $131k-$178k(Glassdoor est.)
    4 days ago 4d
    . Communicates with regulatory agencies under the guidance of the RegulatoryAffairs Department Manager. Plans and executes meetings… Description Under general supervision of the RegulatoryAffairs Department Manager or Director Prepares complex submissions…
  • 2.9
    Relypsa Inc. – Redwood City, CA
    $87k-$126k(Glassdoor est.)
    9 days ago 9d
    Summary: The Manager, RegulatoryAffairs will have broad Regulatory responsibilities and serve as the regulatory lead for designated… documentation (i.e., quality, safety, efficacy, and labeling) to be included in regulatory submissions (e.g., IND, CTA, NDA, MAA) for accuracy…
  • 3.2
    Gilead Sciences – Foster City, CA
    $94k-$128k(Glassdoor est.)
    HOT
    : Represent RegulatoryAffairs on internal and external cross-functional teams, providing regulatoryaffairs support and strategy… local process improvements which have an impact on the RegulatoryAffairs function and/or other departments. As necessary, liaise…
Page 1 of 2