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Senior Regulatory Affairs Specialist - Medical Device

Company: Danaher Corporation
Location: Vista
Posted on: September 18, 2022

Job Description:

In our line of work, life isnt a given - its the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world were located. Creating impactful innovations like ours, doesnt happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career. Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges. Are you a Senior Regulatory Affairs Specialist who would love to be responsible for RA assessment and RA plans for software and product design control activities, regulatory approvals of design documentation and marketing material? Establish documentation for 510k submissions/STED files/China submissions. Understand the requirements of US, EU and other international standards.You will report to Senior Manager, Quality Assurance and Regulatory Affairs and will work with a team of Regulatory Affairs Associates. You will also support other disciplines including but not limited to Quality Assurance, Marketing, Manufacturing, R&D, and Engineering.At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part time at the Company location identified above and part time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.Responsibilities

  • Compile necessary documentation to obtain new international approvals and maintain existing international certification
  • Own the monitoring of legislation. Maintain a detailed understanding of regulatory requirements and ability to translate requirements into lean processes and implement these in the business.
  • Regulatory approvals of design documentation and marketing material
  • Support the preparation of documents for applications (including amendments/supplements), registrations, adverse event and medical device reporting and responses to regulatory agency questions
  • Utilize Danaher Business System (DBS) concepts and tools in the performance of daily activitiesQualifications
    • Bachelors degree a Science discipline, Engineering or equivalent
    • 5+ years in a medical device or pharmaceutical manufacturing environment preferably in Quality or Regulatory Affairs
    • Experience with medical device or pharmaceutical legislation in the US and EU
    • Experience with adverse event and medical device reporting and responses to regulatory agency questionsPreferred Qualifications
      • Experience with software legislation and knowledge of REACH/RoHS
      • Medical device experienceLI-SM1LI-HybridWhen you join us, youll also be joining Danahers global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, youll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System ( tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here ( .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation. If youve ever wondered whats within you, theres no better time to find out.

Keywords: Danaher Corporation, Vista , Senior Regulatory Affairs Specialist - Medical Device, Healthcare , Vista, California

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