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Senior Regulatory Affairs Professional

Job Description

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 60,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Join our team now at Siemens Healthineers as a Senior Regulatory Affairs Professional

Key Responsibilities:

  • Develop strategies and submissions for complex, regulated, medical device products to gain approvals for commercial distribution and clinical research in various geographies
  • Work with the Product team to develop global market strategy for regulatory authorization plans, including product requirements, clinical trials and regulatory communications and submissions, and communicate status updates, issues, and potential issues regarding regulatory plans, regulations, and standards to key stakeholders
  • Lead and prepare relevant regulatory dossiers required for regulatory registration and license applications
  • Ensure that existing approvals and documentation are maintained by monitoring product and labeling changes to assure adherence to regulatory requirements
  • Ensure that post-market surveillance obligations are met, and that requirements for submission of regulatory reports are compliant
  • Stay current on global regulatory requirements and trends with focus on SaMD/AI

Additional task may include

  • Explain regulations, policies, or procedures
  • Maintain data in information systems or databases
  • Ensure compliance with regulations
  • Advise others on regulatory and compliance matters
  • Evaluate applicable laws and regulations to determine impact on company activities
  • Provide technical review of data or reports
  • Coordinate regulatory documentation activities
  • Identify and interpret relevant regulatory guidelines
  • Provide support in audits and inspections by regulatory authorities and certification/accreditation bodies

Required qualifications:

  • Bachelor's degree in health/physical sciences, engineering, a related field, or equivalent practical experience.
  • 7 years of experience in medical device regulatory affairs in global markets
  • Experience in US and international regulation of SaMD
  • Experience in the preparation/clearance of FDA 510(k) submissions and international medical device submissions
  • Familiarity with IEC 62304
  • High level of critical thinking in bringing successful resolution to high impact, complex, and/or cross functional problems
  • Must be able to set priorities as well as adapt to changing priorities

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date.

(Note: Accommodations may be requested for certain medical or religious reasons)

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

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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.

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