Regulatory Affairs Professional

Siemens Healthineers

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. We are seeking a Regulatory Affairs Professional to support our Global Quality/Regulatory Affairs operations for commercially distributed, registered diagnostic products within our Laboratory Solutions portfolio. This role is responsible for maintaining accurate regulatory product data, supporting product releases and market access activities, and ensuring compliance with global regulatory requirements within our ERP systems. The position works closely with cross‑functional and regional teams and plays a key role in enabling uninterrupted product distribution while maintaining the highest standards of regulatory and data integrity.

Requirements

Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical field, or an equivalent combination of education and experience.
3–5 years of experience in the medical device or in vitro diagnostics (IVD) industry.
Experience supporting Regulatory Affairs or regulatory operations activities.
Working knowledge of U.S. and European medical device regulations and market access requirements.
Familiarity with IVD products and related regulatory frameworks.
Experience working with enterprise systems (SAP experience preferred).
Strong proficiency with Microsoft Office tools (Word, Excel); Adobe Acrobat experience preferred.
Excellent attention to detail with the ability to manage regulated data accurately.
Strong organizational, time‑management, and problem‑solving skills.
Ability to work independently while effectively collaborating with global, cross‑functional teams.
Comfortable managing multiple priorities in a fast‑paced, regulated environment.

Responsibilities

Execute regulatory product release, restriction, exclusion, and quoting controls within enterprise systems to support global product distribution.
Provide centralized Regulatory Affairs operational support to project teams, ensuring consistent and compliant execution of regulatory transactions.
Create, manage, and maintain Unique Device Identification (UDI) data for U.S. and EU markets.
Prepare and submit UDI data to regulatory databases, including FDA GUDID (U.S.) and EUDAMED (EU), in accordance with applicable regulations.
Support regulatory master data governance activities, ensuring data accuracy, completeness, and traceability throughout the product lifecycle.
Perform bulk regulatory data updates using system tools when required.
Partner with regional Regulatory Affairs, Quality, Supply Chain, and business teams to resolve product distribution issues such as country blocks or exclusions.
Support quality plans, audits, compliance initiatives, and special regulatory projects.
Contribute to continuous improvement efforts related to regulatory operations, data governance, and system processes.

Benefits

The opportunity to work on products that positively impact patient care and global healthcare delivery.
Exposure to global regulatory processes and collaboration with international teams.
A culture that values quality, compliance, continuous improvement, and professional development.
Competitive compensation and comprehensive benefits package.
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