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Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.
Apply now for the position of Regulatory Affairs Manager, and you will join our Ultrasound Diagnostic Imaging and become part of a dynamic global community of scientists, engineers, clinicians, developers, and professionals who are pushing the boundaries of what’s possible, to improve people’s lives around the world.
In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more.
You will work cross-functionally with R&D, Clinical, Marketing, Quality, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
This is an onsite position in Issaquah, WA office. Remote option can be considered for exceptional candidates.
Your Role:
Develop and implement global regulatory strategies for new product registrations, software updates (including AI-powered features) and product lifecycle management.
Lead preparation and submission of technical documentation and regulatory dossiers to authorities such as NMPA, FDA, EU notified bodies, and other international regulatory agencies.
Oversee and coach a team of regulatory professionals to support both strategic and operational objectives.
Interpret and apply regulatory requirements for medical devices (including IEC/ISO standards, NMPA, FDA 510(k), MDR, etc.).
Define and execute submission strategies to meet timelines and business goals.
Act as liaison to regulatory authorities and internal/external stakeholders; manage interactions and responses during submission review.
Monitor changes in international regulatory environments and communicate impacts to internal teams.
Represent the company in industry groups or regulatory associations, where appropriate.
Support training and knowledge-sharing on country-specific regulatory requirements within the organization.
Your Expertise:
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 utilities, and Software as a Medical Device (SaMD) is preferred.
Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment.
Required Skills, Education and Experience for this position:
BS/MS degree or equivalent experience required. Related engineering, science, regulatory or medical disciplines preferred.
8+ years of regulatory experience in medical device industry, preferably in diagnostic imaging with AI powered features.
Professional certifications, e.g., RAC or other quality and regulatory related certifications are a plus.
Strong organizational, negotiating, and problem-solving skills.
Excellent written and oral English communication skills.
Leadership and presentation skills.
Great judgment and confidence in resolving matters requiring management attention.
Ability to work independently in fast-paced environment and adapt to change.
Willing to travel up to 10%.
Flexibility is expected to participate in global team meetings.
The pay range for this position is $133,900 - $200,900 annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is X% of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html
Equal Employment Opportunity Statement
Siemens Healthineers 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.
Reasonable Accommodations
Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.
If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.
Pay Transparency Non-Discrimination Provision
Siemens Healthineers 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.
Beware of Job Scams
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site.
“Successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”
We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.
To all recruitment agencies:
Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.
How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
To find out more about Siemens Healthineers businesses, please visit our company page here.
The annual base pay for this position is:
Min $133,900 - Max $200,900
Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.
Equal Employment Opportunity Statement: Siemens Healthineers 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.
Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.
If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.
California Privacy Notice: California residents have the right to receive additional notices about their personal information. To learn more, click here.
Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”
Data Privacy: We care about your data privacy (https://www.siemens-healthineers.com/careers/recruitment-application-privacy-notice) and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.
Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.
To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.
