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Senior Regulatory Affairs Specialist, Pharmaceuticals (Remote)

Company: Stryker Group
Location: San Jose
Posted on: May 31, 2024

Job Description:

Why RA/QA at Stryker?Are you interested in working for a global company where you can work across functions and on awide-varietyof projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now!Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team:We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visitingWe are currently seeking a Senior Regulatory Affairs Specialist, Pharmaceuticals to join our Endoscopy Division to be based in San Jose, CA or remotely anywhere within the United States.Who we want

  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Data managers. People who enjoy compiling, organizing and consolidating large volumes of data and reports.
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
  • Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.What you will doAs a Senior Regulatory Affairs Specialist, Pharmaceuticals, on the Pre-Market Regulatory team, you will be supporting fluorescence imaging drug products used in combination with the Open and Minimally Invasive Visualization portfolios within the Endoscopy Business. You will be responsible for preparing complex submissions pertaining to pharmaceutical product approvals for clinical investigations, commercial distribution and/or new/expanded indications by FDA, Health Canada and other regulatory bodies. You will assess post-approval changes to determine the regulatory filing category and ensure compliance by completing thorough regulatory assessments. You will advise personnel on regulatory pathway option(s) and requirements. You will support presentations to health authorities and any related communications.
    • Support regulatory submission strategies and update as needed through investigation and evaluation of regulatory history/ background, classification, disease, and/ or harmonized/ recognized standards, in order to assess regulatory implications for approval.
    • Assess the acceptability of quality, nonclinical and clinical documentation for submission filings to comply with regulatory requirements for clinical investigations and marketing applications and corporate goals, to secure submission approval.
    • Prepare submissions and/ or documents supporting submissions (i.e., CTD summaries) to gain approvals for clinical investigations and/ or commercial distribution, such as: CTAs, INDs, ITAs, (s)NDAs, DINAs, Marketing Authorizations (MA) and Letters to File etc.
    • Ensure that the quality, nonclinical and/or clinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
    • Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding regulatory agency meetings, potential regulatory pathways, clarification, and follow-up of submissions under review.
    • Advise personnel on regulatory requirements for quality, nonclinical and clinical data requirements for clinical study applications and/ or marketing applications.
    • Contribute to evaluations of the regulatory environment and provide regulatory input to product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
    • Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
    • Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures.What you need
      • A Bachelor's Degree (B.S or B.A) required; preferably in Health Science or equivalent focus.
      • A minimum of 3 years of experience in an FDA regulated industry required; preferably within pharmaceuticals.
      • A minimum of 1 year of pre- and/or post-market Regulatory Affairs experience required.
      • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
      • Ability to comply with constantly changing regulatory and clinical environments and prioritize work effectively.
      • Ability to understand and explain detailed regulatory compliance programs and/or issues.
      • Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment.
      • Excellent analytical and writing skills.
      • Advanced PC skills with proficiency in Microsoft office Suite, including Excel.$75,300 - $156,900 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factorsAbout StrykerOur benefits:
        • 12 paid holidays annually
        • Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
        • Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. For a more detailed overview of our benefits or time off, please follow this linkto learn more:About StrykerStryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available atKnow someone at Stryker?Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on ourStryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.
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Keywords: Stryker Group, San Jose , Senior Regulatory Affairs Specialist, Pharmaceuticals (Remote), Healthcare , San Jose, California

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