EDWARDS LIFESCIENCES LLC – $100,922.00/Year

Contd from H.4B Biomedical, Electrical, Mechanical or a related field.br Contd from H.8 In lieu of Masters degree and 3 years of experience, employer will accept a Bachelors degree or equivalent in Sciences Biology, Microbiology, Chemistry, Regulatory, Engineering Biomedical, Electrical, Mechanical or a related field and 5 years of progressive experience in regulatory affairs for medical devices to include any relevant job titles within this occupation.br br Contd from H.12 Job requirements are normal for the employer due to the complexity of job duties associated with this position. Employer answered no to Question H.12 based on SVP analysis only.br br Work experience to include 1. Working with US and EU regulations that affect Class I, Class II and Class III medical devices. 2. Supporting US Class I, Class II and Class III medical devices and 510k submissions, Letter to Files, and RA Plans. 3. Preparing US submissions for FDA and EU product submissions for EU Notified Bodies. 4. Applying regulatory requirements for new products or product changes as they relate to the regulatory impact of Class I, Class II and Class III medical devices. 5. Supporting product development activities for medical devices. 6. Preparing EU submissions under the MDR regulations. 7. Supporting Canada, Australia, and New Zealand submissions for medical devices. 8. Using Microsoft Office Suite including Word, PowerPoint and Excel to write US and EU regulatory submissions and general office communications related to regulatory compliance. 9. Working in a cross functional team RD, Marketing, and Regulatory Affairs and with regulatory partners on new or sustaining projects. 10. Preparing status updates and presenting regulatory plans to stakeholders from crossfunctional teams, regulatory partners and management for approval. Position requires 10 domestic travel; expenses paid by employer.br Hiring Requirements Drug TestingScreening, Background Checks.