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Offers “Siemens”

Expires soon Siemens

Quality Assurance and Regulatory Affairs Professional

  • Internship
  • Portsmouth ( Hampshire )
  • Design / Civil engineering / Industrial engineering

Job description



Job Description

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.

Position Overview

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).

Responsibilities:

· 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

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more,Click here .

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more,Click here .

California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, clickhere .