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Principal Regulatory Affairs Specialist - Neurovascular (remote)

Company: Medtronic GmbH
Location: Irvine
Posted on: January 13, 2022

Job Description:

Principal Regulatory Affairs Specialist - Neurovascular (remote) PRINCIPAL REGULATORY AFFAIRS SPECIALIST - NEUROVASCULAR (remote) In the Neurovascular Operating Unit we are committed to delivering meaningful innovation to advance stroke treatment. You can view more about the business and our products at: - - Our goal as an operating unit is to ensure that we utilize the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident -we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Preference is for this position to be based in Irvine, CA however remote candidates will be considered. Careers That Change Lives As Principal Regulatory Affairs Specialist you will provide regulatory expertise. The incumbent will also be required to provide regulatory advice and assistance to site representatives, requiring travel from time to time to effectively carry out these duties. The Regulatory Affairs Specialist will prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, for PMA, IDE, 510k Notification and to European notified body to support distribution and marketing objective set by divisional and corporate staff. A Day In The Life

  • 510(k) Premarket Notification, PMA, PMA Supplements, PMA Annual Reports, Design Dossier, Technical Files, Australian Technical Files, Canadian Licenses, and Japan submissions.
  • Essential Requirements Checklists, Design Dossiers, Technical Files and Declarations of Conformity for all CE Marked products.
  • Communication with government regulatory agencies and Notified Bodies and serve as regulatory liaison on the project team throughout the product lifecycle.
  • Provide strategic product direction to product teams and cross functional partners to advice on global medical device regulation.
  • Pre-launch checklists for new and existing products to ensure compliance with internal company requirements and compliance with regulatory requirements.
  • Support for requests from Corporate Registrations Team for global growth and expansion.
  • Maintain all regulatory files, both hard and electronic copies, ensuring documentation, registers, directories and lists are complete and up-to-date.
  • Ensure that compliance to standards, pre-clinical and clinical study designs meet regulatory requirements.
  • Support the preparation and maintenance of regulatory submissions as directed.
  • Review and ensure regulatory compliance of internal operational and project documentation involved in commercial product release for all assigned projects. Must Have; Minimum Requirements
    • Bachelor's degree in Science or Engineering (or related field) from an accredited college or university required.
    • Minimum of 7 years of experience medical device regulatory affairs
    • Or advanced degree with a minimum of 5 years of experience medical device regulatory affairs Nice To Have
      • Excellent technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology. -
      • RAPS Professional Certification (RAC)
      • History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.
      • Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
      • Detail-oriented
      • Ability to be flexible with changing priorities
      • Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team.
      • Excellent written and oral communication, technical writing and editing skills.
      • Excellent leadership, interpersonal and influencing skills.
      • Ability to manage multiple projects and proficiency with Microsoft Office and software tools. About Medtronic

        Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

        We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

        Physical Job Requirements

        The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America) It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. Beginning September 30, 2021, Medtronic requires new hires to provide vaccination status against COVID-19 as of their start date. This requirement is a condition of employment at Medtronic and it applies to U.S. employees as of their start date. For access to office sites, if proof of vaccination is not provided a COVID-19 test is required every three days. For patient facing field employees, vaccination may be a requirement of the employment. If you are unable to receive the vaccine due to a health condition or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

Keywords: Medtronic GmbH, Irvine , Principal Regulatory Affairs Specialist - Neurovascular (remote), Education / Teaching , Irvine, California

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