This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Regulatory Affairs Professional in United States.
This role plays a critical part in ensuring global regulatory compliance for diagnostic products within a fast-paced, highly regulated healthcare environment. You will support the operational execution of regulatory processes that enable smooth product distribution and market access across U.S. and European markets.
Working within global Quality and Regulatory Affairs teams, you will ensure the accuracy, integrity, and governance of regulatory product data across enterprise systems.
You will contribute directly to maintaining compliance with international regulations while supporting product releases, data submissions, and lifecycle management activities.
The position requires close collaboration with cross-functional stakeholders across regulatory, quality, supply chain, and business teams.
You will also play a key role in supporting continuous improvement initiatives and ensuring reliable regulatory operations at scale.
This is an excellent opportunity for a detail-oriented regulatory professional who thrives in structured, data-driven, and globally connected environments.
Accountabilities
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
This role plays a critical part in ensuring global regulatory compliance for diagnostic products within a fast-paced, highly regulated healthcare environment. You will support the operational execution of regulatory processes that enable smooth product distribution and market access across U.S. and European markets.
Working within global Quality and Regulatory Affairs teams, you will ensure the accuracy, integrity, and governance of regulatory product data across enterprise systems.
You will contribute directly to maintaining compliance with international regulations while supporting product releases, data submissions, and lifecycle management activities.
The position requires close collaboration with cross-functional stakeholders across regulatory, quality, supply chain, and business teams.
You will also play a key role in supporting continuous improvement initiatives and ensuring reliable regulatory operations at scale.
This is an excellent opportunity for a detail-oriented regulatory professional who thrives in structured, data-driven, and globally connected environments.
Accountabilities
- Execute regulatory product release, restriction, exclusion, and quoting controls within enterprise systems to ensure compliant global product distribution.
- Maintain and support regulatory master data governance, ensuring accuracy, traceability, and completeness across product lifecycle systems.
- Create, manage, and submit Unique Device Identification (UDI) data for U.S. (FDA GUDID) and EU (EUDAMED) regulatory databases.
- Provide operational regulatory support to project teams, ensuring consistent execution of regulatory transactions across regions.
- Perform bulk updates and maintenance of regulatory data using enterprise tools such as SAP or equivalent systems.
- Collaborate with regulatory, quality, supply chain, and business teams to resolve distribution and compliance issues such as country restrictions or exclusions.
- Support audits, quality initiatives, and regulatory compliance projects while contributing to continuous improvement efforts.
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or a related technical field (or equivalent experience).
- 3-5 years of experience in the medical device or in vitro diagnostics (IVD) industry.
- Experience in Regulatory Affairs, regulatory operations, or compliance-focused roles.
- Working knowledge of U.S. and European medical device regulations and market access requirements.
- Strong understanding of IVD products and associated regulatory frameworks.
- Experience working with enterprise systems (SAP preferred) and strong proficiency in Microsoft Office tools.
- High attention to detail with strong data management and documentation accuracy skills.
- Excellent organizational, problem-solving, and time-management abilities in a regulated, fast-paced environment.
- Ability to work independently while collaborating effectively across global, cross-functional teams.
- Competitive compensation package aligned with experience and market standards.
- Comprehensive health coverage including medical, dental, and vision insurance.
- Retirement savings plan (401k) and financial wellbeing support.
- Life, short-term, and long-term disability insurance.
- Paid time off, sick leave, and additional wellness-related benefits.
- Opportunity to work in a global healthcare environment with strong mission impact.
- Exposure to international regulatory systems and cross-functional collaboration.
- Professional development within a leading medical technology organization.
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.