Senior Regulatory Affairs Specialist

Siemens Healthineers

1d•$126,760 - $174,295

About The Position

The Senior Regulatory Affairs Specialist prepares, submits, and maintains regulatory submissions and lifecycle documentation, including FDA 510(k) submissions, notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications. The role serves as a regulatory subject matter expert, advising design control activities and new product development teams, and prepares and maintains Technical Files in compliance with applicable requirements and the Quality Management System. The specialist collaborates across functions to develop and maintain quality guidelines, procedures, and work instructions; leads or contributes to regulatory projects; trains internal stakeholders on country-specific requirements; and reviews promotional and labeling materials for regulatory compliance. The role also supports audit- and inspection-ready documentation, advises teams on regulatory documentation practices, and participates in internal and external audits, design dossier reviews, and regulatory authority inspections as applicable. The role calls for knowledge of US and EU medical-device regulations and standards, familiarity with point-of-care IVD products and their applicable regulations, strong communication and presentation skills, attention to detail, adaptability, and the ability to multitask in a dynamic environment.

Requirements

Bachelor’s degree in a scientific discipline.
At least 7 years of experience in IVDs or medical devices.
Solid working knowledge and experience with US and EU regulations and standards applicable to medical-device market clearance.
Experience working in a GMP environment.
Proficiency with Outlook, SharePoint, Adobe Acrobat, and Microsoft Office applications, including Excel, and Azure DevOps.
Intercultural sensitivity.
Strong attention to detail and excellent organizational skills.
Very good presentation, communication, and team-orientation skills.
Ability to collaborate across functions, multitask, and work effectively in a dynamic environment.

Nice To Haves

Knowledge of point-of-care IVD products and applicable regulations for those products.
Nimble learning and an active approach to seeking relevant legislation and competitive information.

Responsibilities

Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions, notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications.
Provide regulatory subject-matter expertise and guidance for 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.
Collaborate with cross-functional teams to develop and maintain quality guidelines, procedures, and work instructions that support regulatory compliance.
Lead or contribute to regulatory projects, ensuring timely execution and alignment with regulatory strategy.
Train internal stakeholders on country-specific regulatory requirements, as applicable.
Review promotional and labeling materials for compliance with country-specific regulatory requirements.
Ensure documentation is audit- and inspection-ready and guide cross-functional teams on regulatory documentation practices.
Participate in internal and external audits, including quality system audits, design dossier reviews, and regulatory authority inspections, as applicable.
Seek out relevant legislation and competitive information on product lines.