Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Senior Regulatory Affairs Specialist to build and deliver on competitive regulatory strategies.
Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Senior Regulatory Affairs Specialist, you will be responsible for:
- Provides regulatory information and guidance for product development and planning throughout the product lifecycle
- Regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance
- Plans and prepares product related medical device submissions with Siemens internal or external organizations according to regulatory requirements
- Submits required documentation/information to local authorities (e.g., USA FDA, EU NB) or Siemens internally
- Advises project steering groups on regulatory strategy and requirements for specific new products/solution
- Identifies potential regulatory approval risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project
- Identifies, analyzes and implements country specific requirements necessary for product related submission
- Performs review of promotional material and products being introduced into a market for regulatory compliance according to country specific requirements
This position may suit you best if you are familiar
with what is below, and would like to do develop your career with
- Expertise with global medical device regulations and registration processes, especially USA 510(k) and EU MDR
- Superior presentation skills when communicating with all levels of the organization, business partners, and external sources.
- Knowledge of Artificial Intelligence and Machine Learning (AI/ML) Enabled Medical Devices is highly desired
- Experiences with diagnostic ultrasound and its clinical usefulness, and Software as a Medical Device (SaMD) is preferred
- You will be working with our latest technology and therefore you are willing to learn about new software and hardware solutions
- Willingness to travel and flexibility is expected
Required skills to have for the success of this role
- 8+ years of regulatory experience in medical tech industry
- BS/MS degree or equivalent experience. Related engineering, science, regulatory or medical disciplines preferred
- Strong organizational, negotiating, and problem-solving skills
- Excellent written and oral English communication skills; demonstrated public speaking skills
- Ability to work independently in fast-paced environment and adapt to change
- Willing to travel up to 10%
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, except where prohibited by state law. Accommodations may be requested for certain medical or religious reasons. If you choose to submit an accommodation request it should be submitted within 3 business days of receiving a verbal offer. Details on how to submit approval will be provided by your recruiter. An accommodation approval must be confirmed prior to your start date. A start date cannot be confirmed until the accommodation has been reviewed. An accommodation is based on your role. If you are a currently a Siemens Healthineers employee with an existing approved accommodation, it will need to be re-evaluated prior to starting a new role.
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.
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Full / Part time: 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, click here.