Regulatory Affairs Professional

Siemens Healthineers

19h

About The Position

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. This is a role well suited to an ambitious professional, looking for the next step in their career. As a Regulatory Affairs Professional, you will be responsible for preparing, submitting, and maintaining regulatory submissions and lifecycle documentation, serving as a subject matter expert, and collaborating with cross-functional teams to ensure compliance and support new product development. The role also involves leading regulatory projects, providing training, reviewing promotional materials, ensuring audit-ready documentation, and participating in internal and external audits. Siemens Healthineers is a global team of more than 72,000 dedicated professionals in over 70 countries, leading in medical technology to create better outcomes and experiences for patients worldwide. The company fosters a culture of inclusivity, believing in each individual's potential to contribute diverse ideas and work together to fight diseases and enable access to care, united by the purpose of pioneering breakthroughs in healthcare sustainably.

Requirements

Bachelor’s degree in scientific discipline
Minimum of 2 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
Ability to work with controlled technology in accordance with US export control law.

Nice To Haves

Solid working knowledge and experience of the US/EU regulations and standards applicable to medical device market clearance.
Knowledge of IVD products and applicable regulations for such products
Very good presentation skills
Team orientation and communication skills.
Ability to ensure cross-functional collaboration and cooperation.
Excellent attention to details.
Able to multi-task and work effectively in a dynamic environment.

Responsibilities

Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA PMA Annual Reports, PMA 30‑day notices and supplements, 510(k) submissions and notes to file, IVDR Class D 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, regulatory authority inspections, and DEA audits, as applicable.