Jobs
>
Palo Alto

    Senior Regulatory Affairs Specialist - Palo Alto, United States - Comrise

    Comrise
    Comrise Palo Alto, United States

    1 week ago

    Default job background
    Description

    Payrate: 68.89/hr

    Duration: 12 months

    Position Description:

    • Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements
    • Identifies, analyzes and implements country specific requirements necessary for product related submissions.
    • Recommend strategies for earliest possible approvals for marketing applications
    • Performs regulatory projects or acts as a member of the project steering group.
    • Submits required documentation/information to local authorities or company internal.
    • Initiates and escalates necessary activities if deviations are identified.
    • Ensures creation of adequate documentation for audits/inspections.
    • Performs training within the organization in country specific regulatory requirements, if applicable.
    • Write and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance.
    • Performs review of promotional material for regulatory compliance according to country specific requirements.

    Qualifications

    Experience: 5-8 years.

    Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches

    Product Registration Experience:

    Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files

    Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.

    Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).

    Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO as evidenced by coursework or submissions that required use of each standard

    Teamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.

    Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.

  • CONFLUX SYSTEMS

    Senior Regulatory Affairs Specialist

    3 weeks ago

    CONFLUX SYSTEMS Palo Alto, United States

    Here are the job details for your review: · Job Title: Sr. Regulatory Affairs Specialist · Job Location : 911 Hansen Way, Bldg 3, Palo Alto, CA Hybrid) · Pay Rate: $68.89/HR on W2 · Duration: 12+ Months (Possibility of extension) · Client Name : Siemens · Shift Hours : 8am-5pm · ...

  • Net2source Inc.

    Regulatory Affairs Specialist

    2 weeks ago

    Net2source Inc. Palo Alto, United States

    Job Title: Regulatory Affairs Professional 4Duration: 12 months (Possible Extension )Location: Palo Alto CA Hybrid)Experience: 5-8 years.Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various cont ...

  • Hired by Matrix

    Sr. Regulatory Affairs Specialist

    1 week ago

    Hired by Matrix Palo Alto, United States

    Do you want more than just another job? Are you ready to team up with an organization that values your contributions? Then Hired by Matrix is for you · Working with some of the US' premier companies, we excel at connecting candidates with positive cultures and dynamic teams · W ...

  • Comrise

    Senior Regulatory Affairs Specialist

    2 weeks ago

    Comrise Palo Alto, United States

    Payrate: 68.89/hr · Duration: 12 months · Position Description: · Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements · Identifies, analyzes and implements country specific requirem ...

  • Hired by Matrix

    Sr. Regulatory Affairs Specialist

    3 weeks ago

    Hired by Matrix Palo Alto, United States

    Job Description · Job Description · REMOTE Job · What You'll Do: · Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements. · Identifies, analyzes and implements country specific req ...

  • estaffing Inc

    Sr. Regulatory Affairs Specialist

    2 days ago

    estaffing Inc Palo Alto, United States

    Job Description · Job DescriptionPosition Description: · *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements · * Identifies, analyzes and implements country specific requirements n ...

  • BioLink 360

    Principal Regulatory Affairs Specialist

    2 weeks ago

    BioLink 360 Mountain View, United States

    Reports to: Senior Director of Regulatory and Quality · Salary Range: K · Location: San Jose, CA (hybrid position) · This is an established privately held medical device company with a focus in delivering innovative navigation diagnostic and therapeutic technologies. Their reach ...

  • Hired by Matrix

    Sr. Regulatory Affairs Specialist

    3 weeks ago

    Hired by Matrix Palo Alto, United States

    Do you want more than just another job? Are you ready to team up with an organization that values your contributions? Then Hired by Matrix is for you · Working with some of the US' premier companies, we excel at connecting candidates with positive cultures and dynamic teams. We e ...

  • Hired by Matrix

    Sr. Regulatory Affairs Specialist

    3 weeks ago

    Hired by Matrix Palo Alto, United States

    Do you want more than just another job? Are you ready to team up with an organization that values your contributions? Then Hired by Matrix is for you · Working with some of the US' premier companies, we excel at connecting candidates with positive cultures and dynamic teams. We ...

  • GForce Life Sciences

    Regulatory Affairs Specialist

    1 week ago

    GForce Life Sciences Santa Clara, United States

    Regulatory Affairs Specialist– Santa Clara, CA · Must be able to work on a W2 · Job Summary: We are seeking a regulatory affairs specialist to assist and lead in the definition/implementation of regulatory strategy and priorities in conjunction with management, peers, and comme ...

  • Pulmonx

    Senior Regulatory Affairs Specialist

    2 weeks ago

    Pulmonx Redwood City, United States

    Pulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CA · Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements. · Not sure who ...

  • Comrise

    Senior Regulatory Affairs Specialist

    3 weeks ago

    Comrise Palo Alto, United States

    Payrate: 68.89/hr · Duration: 12 months · Position Description: · Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements · Identifies, analyzes and implements country specific requirem ...

  • Pulmonx

    Senior Regulatory Affairs Specialist

    2 weeks ago

    Pulmonx Redwood City, United States

    Pulmonx · is looking for an experienced · Sr Regulatory Affairs Specialist · to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: ...

  • Cepheid

    Regulatory Affairs Senior Specialist

    2 weeks ago

    Cepheid Sunnyvale, United States

    At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved ...

  • Pulmonx

    Senior Regulatory Affairs Specialist

    1 week ago

    Pulmonx Redwood City, United States

    Pulmonx · is looking for an experienced · Sr Regulatory Affairs Specialist · to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: ...

  • Pulmonx

    Senior Regulatory Affairs Specialist

    2 weeks ago

    Pulmonx Redwood City, United States

    Pulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CA · Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: · Resp ...

  • Nevro

    Senior Regulatory Affairs Specialist

    19 hours ago

    Nevro Redwood City, United States

    About Nevro: · Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The comp ...

  • Pulmonx

    Senior Regulatory Affairs Specialist

    1 week ago

    Pulmonx Redwood City, United States

    Pulmonx is looking for an experienced Sr Regulatory Affairs Specialist to join our dynamic Regulatory Affairs Team in Redwood City, CANot sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: and capabil ...

  • GForce Life Sciences

    Regulatory Affairs Specialist

    2 weeks ago

    GForce Life Sciences Santa Clara, United States

    Regulatory Affairs Specialist II – Santa Clara, CA · Must be able to work on a W2 · Job Summary · We're looking for a Regulatory Specialist with 2-5 years of experience in the medical device industry. Your responsibilities include maintaining the quality system, supporting manu ...

  • Hired by Matrix

    Sr. Regulatory Affairs Specialist

    4 weeks ago

    Hired by Matrix Palo Alto, United States

    Job Description · Job DescriptionREMOTE Job · What You'll Do: · Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements. · Identifies, analyzes and implements country specific requireme ...