Senior Regulatory Affairs Specialist

Siemens Healthcare; USA; Vor Ort; USD 127.000 - 174.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Paid time off

Paid sick and safe time

Zusammenfassung

Siemens Healthineers in the United States is seeking an experienced Regulatory Affairs professional to prepare and maintain regulatory submissions for US FDA and international markets. You will collaborate with design control and product development teams to ensure compliant technical files and QMS documentation.

The role demands leadership in audits, inspections, and cross‑functional training on regulatory requirements, with emphasis on accuracy, attention to detail, and effective communication

Qualifikationen

• Bachelor's degree in scientific discipline.
• Minimum of 7 years of experience in IVDs or Medical devices.
• GMP environment experience.
• Strong attention to detail and organizational skills.
• Intercultural sensitivity and effective communication.

Aufgaben

• Prepare, submit, and maintain regulatory submissions, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required.
• Serve as 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 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.

Kenntnisse

Regulatory knowledge

Communication skills

Cross-functional collaboration

Attention to detail

Multitasking

Ausbildung

Bachelor's degree in scientific discipline

Tools

Outlook

SharePoint

Adobe Acrobat

Microsoft Office

Excel

Azure DevOps

Jobbeschreibung

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 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

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.

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 Aff… 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, physic