In H.8A through H.8C In lieu of a Masters degree and 8 years of experience employer will accept a Bachelors degree or equivalent in Regulatory Affairs, sciences Biology, Microbiology, Chemistry, or a related field and 10 years of progressive experience in regulatory affairs within the medical device industry.br br 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 European regulations relevant to Class II or Class III medical devices. 2. Working with global regulatory requirements for new medical products or product changes. 3. Providing review and input of protocols and reports for design verification, design validation, process qualifications, biocompatibility studies, shelf life, preclinical studies, and clinical studies. 4. Writing and submitting technical documents including 510ks, IDEs, PMAs, CE design dossiertechnical files and clinical trial protocols and updates utilizing productrelated technical documentation preclinical, clinical, manufacturing and quality reports and procedures. 5. Reviewing design change control documents, validation reports, and post market product surveillance reports. 6. Working in crossfunctional project teams as a representative of the regulatory affairs function. 7. Determining regulatory paths for new product development and product and process changes. 8. Preparing status updates and written reports and presenting arguments for regulatory plans to stakeholders from crossfunctional teams and management for approval. 9. Evaluating new medical product development projects across at least 2 product portfolios simultaneously to identify the relationships and points of leverage. 10. Utilizing business management computer systems. 11. Consulting experience in project setting within cardiovascular devices.br br Hiring Requirements Drug TestingScreening, Background Check.

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