Regulatory Affairs Professional

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.

Key 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.

 

Required Qualifications:

Education

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical field, or an equivalent combination of education and experience.

 

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.

 

Skills & Competencies

• 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.

 

What We Offer

• 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.

 

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:

$81,780 - $112,453

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 Affirmative Action Employer 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, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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