Senior Regulatory Affairs Specialist
Siemens Healthineers
Summary
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.
Job description
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.
Preferred Qualifications
- 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
- Very good presentation skills, team orientation and communication skills
- Cross-functional collaboration and cooperation
- Excellent attention to detail
- Able to multi-task and work effectively in a dynamic environment
- Nimble learning and ability to actively seek out relevant legislation and competitive information on product lines
Requirements
- 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
Benefits
- Medical, Dental & Vision
- 401(k) Retirement Plan
- Life Insurance
- Long-term Disability Insurance
- Short-term Disability Insurance
- Paid Parking/Public Transportation
- Paid Time Off
- Paid Sick and Safe Time
Company overview
Siemens Healthineers is a German multinational medical technology company specializing in diagnostic and therapeutic imaging, laboratory diagnostics, and molecular medicine. Founded in 2017 as a spin-off from Siemens AG, the company has established itself as a global leader in healthcare technology with a comprehensive portfolio that addresses the complete care continuum for many of the world's most threatening diseases. With approximately 69,500 employees worldwide and operations in over 70 countries, Siemens Healthineers generates annual revenues exceeding €21 billion. The company's product offerings span across four main business segments: Imaging (including CT, MRI, ultrasound, and X-ray systems), Diagnostics (laboratory and point-of-care testing), Varian (cancer care and radiation therapy), and Advanced Therapies. Siemens Healthineers is particularly renowned for pioneering breakthroughs in medical imaging, having developed the world's first commercial PET/CT scanner and continuing to innovate in areas such as artificial intelligence, digital health solutions, and precision therapy. The company's commitment to research and development, with annual investments of approximately €1.5 billion, drives its mission to pioneer breakthroughs in healthcare for everyone, everywhere, sustainably.