Dedicated 2 Imaging is a small R&D center for Siemens Healthineers. This role will be responsible for working with headquarters in Germany to transfer products from R&D to production.
As a Quality Assurance and Regulatory Affairs professional, you will be responsible for maintaining and ensuring that the company quality system meets FDA, Canadian, ISO 13485, and all international market medical device requirements. You will also be responsible for ensuring that products and their labeling meet all regulatory requirements (national and international).
· Implement all quality procedures.
· Manage and maintain compliance with FDA QSRs (GMP) including company registration, new product submissions, establishing FDA communication/channels for compliance on medical device listings/classifications, management of CAPA system.
· Manage and maintain compliance with the EU market MDD 93/42/EEC directive and the Canadian MDR (including CE Mark applications or self-declarations via technical files).
· Manage and maintain certification of ISO 13485 requirements.
· Responsible for working with R&D and manufacturing to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing.
· Conduct internal audits and coordinate and manage external ISO audit schedules, correspondence and closing of findings.
· Audit Design history files for new products for FDA compliance, if needed.
· Responsible for reviewing and establishing the company quality goals each year.
· Responsible for meeting regulatory requirements in foreign countries for registration of medical products.
· Responsible for the Documentation Control Process and Documentation Change Control Process.
Required Knowledge/Skills, Education, and Experience
· Bachelor of Science degree required.
· Experience in cGMP and other Regulatory compliance requirements.
· Experienced in regulatory filings for US 510(k) and other key countries/regions.
· Some international travel required.
Preferred Knowledge/Skills, Education, and Experience
· Considerable experience in Quality Assurance and Regulatory Affairs (Seven + years)
· Medical imaging quality and regulatory experience preferred.
· Experience with all phases of the product development lifecycle, including concept, design, implementation,
· verification and validation activities necessary for product commercialization strongly preferred.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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