Principle/Staff Regulatory Specialist

Mojo Vision

Saratoga, CA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Post Date: 05/06/2021
  • Website: mojo.vision
  • Company Address: , Saratoga, CA, 95070

About Mojo Vision

Mojo Vision is the Invisible Computing Company, dedicated to developing products and platforms that re-imagine the intersection of ideas, information and people. Instead of being tethered to devices that are increasingly a distraction in many aspects of our lives, Mojo envisions delivering information and knowledge that is immediate, but without the disruption of traditional devices. Mojo is inventing the future of computing - Invisible Computing - which imagines a world where information is there when you need it, technology fades away, and you can freely connect with others in a more meaningful and confident way. Founded by technology experts with decades of experience developing pioneering products and platforms and backed by some of the world’s leading technology investors, Mojo believes the future is invisible.

Job Description

At Mojo, we’re inventing the future of computing – Invisible Computing – which imagines a world where information is there when you need it, technology fades away, and you can freely connect with others in a more meaningful and confident way. Our team includes talented professionals with expertise in product design, user experience, applied physics, hardware, software, optics, photonics, electronics, chemistry, biology and vision science. Together, we’re building Mojo Lens, a smart contact lens with a built-in display that gives you timely information without interrupting your focus. Mojo Lens elevates your vision by providing the information you need exactly when it's needed - all while letting you look like you.
 
We are a well-funded startup founded by technology experts with decades of experience developing pioneering products and platforms and backed by some of the world’s leading technology investors. We are located in Saratoga, CA.
 
Assist with the preparation and maintenance of new and existing regulatory applications including investigational and marketing applications (e.g. 510(k)s, De Novos, PMAs, etc.), amendments, supplements, and other submissions in compliance with health authority regulations

Responsibilities

    • Assess the acceptability of quality, preclinical and clinical documentation for premarket submission filing
    • Compile, prepare, review and submit regulatory submission to authorities; interact with regulatory to answer questions in a timely manner
    • Provide strategic input, technical and compliance guidance on regulatory requirements to project teams and other regulatory personnel
    • Utilize technical regulatory skills to propose strategies on complex issues
    • Maintain associated regulatory files for related projects
    • Gather medical device data from databases and literature searches
    • Interact with various regulatory agencies, contract groups, and partner organizations, as needed
    • Work closely with clinical to ensure protocols and analytical plan will provide appropriate data to support regulatory submission
    • Monitor applications under regulatory review
    • Communicate application progress to all appropriate departmental personnel
    • Monitor impact of changing regulations on submission strategies and update all appropriate departmental personnel
    • Develop and maintain regulatory processes and SOPs to ensure compliance with latest applicable regulations
    • Assist with label development and review for compliance before release
    • Support product registration and post-approval activities
    • Organize plan for compliance with product post-marketing approval requirements, maintaining annual licenses, registrations, update Technical Files / Design Dossiers

Minimum Qualification

    • BA/BS degree, preferably in a scientific field.
    • 10 years of experience in the device/biopharmaceutical industry, including 5 year in a regulatory affairs-medical devices role.
    • Ability to contribute to strategic development in regard to regulatory approach for premarket products (FDA, EU, APAC)
    • Confident writer, able to organize and draft documents with little or no previous samples
    • Excellent organizational, multitasking, and communication skills.
    • Strong attention to detail, organization and accuracy
    • Proficiency with MS Office suite, Adobe Acrobat

Preferred Qualifications

    • Master’s degree
    • RAC certification
    • Experience on project teams (new product development) with submissions to regulatory bodies
    • Comfortable working independently and as part of a team on multiple projects with ability to prioritize effectively
If solving challenging problems and shaping the future interests you, come join us at our offices in Saratoga, CA just outside of San Jose. Along with competitive compensation employee perks include flexible time off, access to full health benefits and a stocked fridge and pantry in the office. Even if you don’t see your dream job on our openings page, you can still apply for it with the “Create your own position” option.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.