Overview
Remote
$80+
Contract - W2
Contract - Independent
Skills
Regulatory
EUDAMED
Job Details
Summary: We are seeking a highly technical and detail-oriented Regulatory Systems Manager to oversee our digital compliance and submission activities. This role is critical for managing our interactions with global health authorities, including the FDA and the EU's EUDAMED database, through modern electronic data exchange protocols.
Key Responsibilities:
- EUDAMED Management: Serve as the company's subject matter expert (SME) for the EUDAMED database, responsible for data submission, device registration, vigilance reporting, and ensuring ongoing compliance with EU MDR requirements.
- Electronic Data Interchange: Manage and execute the secure exchange of regulatory data using AS4 and other applicable standards for B2B communications with EUDAMED and other global authorities.
- System Integration & APIs: Design, implement, and maintain API and Machine-to-Machine (M2M) integrations between internal systems (e.g., PLM, ERP) and external regulatory portals to automate data flow and reduce manual entry.
- FDA Submissions: Oversee the technical aspects of electronic submissions to the FDA, including eCopy, ESG, and UDI submissions, ensuring compliance with specified formats and protocols.
- Strategy & Process Improvement: Identify and lead projects to digitize and automate regulatory processes, improving data accuracy, efficiency, and submission speed.
- Training & Support: Train Regulatory Affairs colleagues and other stakeholders on the use of regulatory systems and electronic submission processes.
Required Qualifications & Skills:
- Bachelor's degree in Computer Science, Information Systems, Engineering, or a related life science field.
- 5+ years of experience in the medical device industry, with a strong focus on regulatory systems.
- Hands-on, practical experience with the EUDAMED database and a deep understanding of EU MDR data requirements.
- Proven technical expertise in data exchange standards, specifically AS4, and experience with REST/SOAP APIs and M2M communication.
- Experience with FDA electronic submission systems (e.g., FURLS, CDRH, ESG).
- Strong understanding of regulatory information management (RIM) systems and processes.
- Excellent problem-solving and analytical skills.
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