Senior Regulatory Affairs Specialist

Siemens Healthineers AG; Idaho; On-site; USD 127,000 - 174,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Commuter benefits

Paid time off

Sick leave

Job summary

Siemens Healthineers AG in the United States is seeking a Regulatory Affairs expert to prepare and manage regulatory submissions, including FDA 510(k) and IVDR/File lifecycle documentation. You will guide product development teams on regulatory strategy and ensure QMS alignment across functions.

The role emphasizes cross‑functional collaboration, meticulous attention to detail, and strong knowledge of GMP standards. Prior experience with medical devices and IVDs is highly valued.

Qualifications

• Bachelor’s degree in a scientific field; relevant regulatory experience a plus.

Responsibilities

• Prepare, submit, and maintain regulatory submissions (FDA 510(k) etc.) and lifecycle docs.
• Lead regulatory projects and guide design control activities with cross‑functional teams.
• Ensure audit- and inspection-ready documentation and QMS alignment.
• Review promotional and labeling materials for regulatory compliance.
• Provide training on country-specific regulatory requirements where applicable.
• Support cross-functional teams on regulatory documentation practices.

Skills

Regulatory affairs

FDA regulations

I​VD/medical devices

Cross-functional collaboration

Attention to detail

Regulatory strategy

GMP experience

Presentation skills

Education

Bachelor's degree in scientific discipline

Tools

Azure DevOps

SharePoint

Excel

Adobe Acrobat

Job description

Who we are:

We are a team of more than 72,000 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 base pay range for this position is:

$126,760 - $174,295. 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.

Benefits for this position:

• 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 Aff

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 [e-mail].

Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

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.”

Job Responsibilities:

Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR ClassC recertifications, significant change notifications, and other regulatory applications as required. Serve as a Regulatory Affairs subject matter expert, providing guidance to design control activities and new product development teams. Prepare, submit, and maintain Technical Files in compliance with applicable regulatory requirements and the Quality Management System (QMS). Collaborate with cross‑functional teams to develop and maintain quality guidelines, procedures, and work instructions that support ongoing regulatory compliance. Independently or collaboratively lead and contribute to regulatory projects, ensuring timely execution and alignment with regulatory strategy. Provide training to internal stakeholders on country‑specific regulatory requirements, as applicable. Independently or as part of a team, review promotional and labeling materials for regulatory compliance in accordance with country‑specific requirements. Ensure audit‑ and inspection‑ready documentation and provide guidance to cross‑functional teams on appropriate regulatory documentation practices. Participate in internal and external audits, including quality system audits, design dossier reviews, and regulatory authority inspections, as applicable.

Candidate Profile:

This position may suit you best if you are familiar with what is below, and you would like to do develop your career with Healthineers: Solid working knowledge and experience of the US/EU regulations and standards applicable to medical device market clearance Knowledge of point-of-care IVD products and applicable regulations for such products You have very good presentation skills, and you show team orientation and communication skills. Ensure cross‑functional collaboration and cooperation. Excellent attention to details. Able to multi‑task and work effectively in a dynamic environment. Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines. Required skills to have for the success of this role: Bachelor’s degree in scientific discipline Minimum of 7 years of experience in IVDs or Medical devices Skilled in Outlook, SharePoint, Adobe Acrobat, and Microsoft Office applications, including Excel and Azure DevOps Experience of working in a GMP environment Intercultural sensitivity Strong attention to detail and excellent organizational skills.