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 48,000 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 Regulatory Technical Specialist 3
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Regulatory Technical Specialist 3, you will be responsible for:
You will be responsible for the compilation, submission and maintenance of 510(k) pre-market notifications and international regulatory filings.
You will serve as the Regulatory representative in project development teams to develop a global regulatory strategy to ensure timely market access of new products
You will coordinate worldwide product licensing activities including the gathering of data and the submission of registration documents to in-country Siemens Regulatory Representatives
You will ensure promotional material are compliant with the product regulatory clearances/approvals
You will stay current on global regulatory requirements and will be engaged in the implementation of new regulations
This position may suit you best if you are familiar with what is below, and would like to develop your career with Healthineers
You have demonstrated an excellent working knowledge of FDA 510(k) pre-market notification requirements through successful submissions
You have an in-depth understanding of EU medical device requirements (MDD and MDR)
You have a general understanding of Quality System Requirements (FDA QSR and ISO 13485)
You have a working knowledge of the medical device regulations in China, Canada and Japan
You thrive in a fast paced environment while having a flexible workstyle
You have good communication and presentation skills
Required skills to have for the success of this role
Minimum 5 – 8 years of regulatory experience in the medical device industry
Ability to travel up to 15%
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.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
EEO is the Law Applicants and employees are protected under Federal law from discrimination.