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Senior Regulatory Affairs Specialist, Software Interoperability (Remote)

Company: stryker
Location: San Jose
Posted on: November 19, 2021

Job Description:

Work Flexibility: Remote

We are currently seeking a Senior Regulatory Affairs Specialist, Software Interoperability 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.
  • Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
  • 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 do

    As the Senior Regulatory Affairs Specialist, Software Interoperability you will be responsible to develop and execute global regulatory strategy for new and/or modified medical devices, to gain approvals for both clinical investigations and commercial distribution. You will advise product / project development teams on regulatory pathway option(s) and requirements. You will be responsible to prepare complex submissions and/or presentations to health authorities and for any related communications. You will support the cutting edge of integrated operating rooms, leveraging advanced software and hardware applications to improve OR efficiency and patient outcomes.
    • Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Qsub, Shonin, Design Dossier and Technical File.
    • Apply software and security (i.e., cybersecurity, AI/ML) regulatory standards, guidance documents, and industry expectations to product strategies and submissions. Guides others in the organization who are working on similar products.
    • Interact across corporation or in industry settings to influence software, interoperability and cybersecurity related regulatory items.
    • Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing 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.
    • Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
    • Lead negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.
    • Advise personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications.
    • Provide regulatory input to product lifecycle planning.
    • Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
    • Review of advertising and promotional items.
    • Assist in SOP development and review.
      What you need
      • A Bachelor's Degree (B.S or B.A) required, preferably in Engineering, Science or equivalent focus preferred.
      • A minimum of 3 years of experience in an FDA regulated industry required.
      • A minimum of 1 year of pre-market Regulatory Affairs experience.
      • Software-related regulatory experience preferred (e.g., IEC62304, FDA Software/Cybersecurity Guidance Documents, AI/ML).
      • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
      • Ability to understand and explain detailed regulatory compliance programs and/or issues.
      • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
      • Ability to analyze and resolve non-routine regulatory issues using independent judgment.
      • Excellent analytical and writing skills.
      • Excellent interpersonal, written and oral communication skills.
      • Effective organizational skills.
      • Advanced PC skills with proficiency in Microsoft office Suite, including Excel.
        This job may be performed remotely from the locations listed above; except that this job may not be filled or performed in Colorado.

        Travel Percentage: 10%

        Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

        Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

Keywords: stryker, San Jose , Senior Regulatory Affairs Specialist, Software Interoperability (Remote), IT / Software / Systems , San Jose, California

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