Senior Regulatory Affairs Specialist

Siemens Healthineers AG; United States; Remote; 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

Paid parking

Paid time off

Paid sick time

Job summary

Siemens Healthineers AG is seeking a Regulatory Affairs expert to prepare, submit, and maintain regulatory submissions and lifecycle documentation for medical devices and IVDs in the US market. You will guide design controls, collaborate with cross‑functional teams, and ensure compliance with FDA requirements.

You will review promotional materials, participate in audits, and train internal stakeholders on country-specific regulatory requirements, helping to sustain quality systems and regulatory

Qualifications

• Bachelor’s degree in a scientific field and strong regulatory knowledge.
• Minimum 7 years experience in IVDs or medical devices.
• Experience with GMP and regulatory submissions (FDA/US and EU/IVDR).

Responsibilities

• Prepare, submit, and maintain regulatory submissions and lifecycle documentation.
• Lead design control activities and provide regulatory guidance to product teams.
• Review promotional and labeling materials for compliance with country rules.
• Support internal audits and supplier quality documentation.
• Provide training on regulatory requirements to stakeholders.

Skills

Regulatory affairs

GMP experience

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in scientific discipline

Tools

Outlook

SharePoint

Adobe Acrobat

Azure DevOps

Excel

Microsoft Office

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.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.Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C 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.This position may suit you best if you are familiar with what is below, and 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 productsYou 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 disciplineMinimum of 7 years of experience in IVDs or Medical devicesSkilled in Outlook, SharePoint, Adobe Acrobat, and Microsoft Office applications, including Excel and Azure DevOpsExperience of working in a GMP environmentIntercultural sensitivityStrong attention to detail and excellent organizational skillsWho 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 - $174,295Factors 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. 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 [e-mail]. 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 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.