Regulatory Specialist II - Intellectt : Job Details

Role: Regulatory Specialist II

Location: Des Plaines, IL

Duration: 12 Months

Position Overview

We are seeking a detail-oriented and experienced Regulatory Specialist with expertise in European Union Medical Device Regulation (EU MDR) to join our team in the medical or pharmaceutical industry. The successful candidate will be responsible for ensuring that our products comply with global and EU-specific regulatory requirements, managing submissions, and supporting regulatory strategies to facilitate market access.

Key Responsibilities

• Regulatory Compliance: Ensure product compliance with EU MDR requirements, as well as other global regulations (e.g., ISO 13485, FDA 21 CFR Part 820).
• Documentation Management: Prepare, review, and submit Technical Documentation (TD) and other regulatory dossiers required for CE marking.
• Regulatory Submissions: Support and manage regulatory submissions, renewals, and updates, including EU declarations of conformity and notified body interactions.
• Risk Management: Collaborate with cross-functional teams to ensure risk management processes (ISO 14971) are integrated into regulatory documentation.
• Post-Market Surveillance (PMS): Assist in the development and maintenance of PMS reports, Periodic Safety Update Reports (PSURs), and vigilance activities in compliance with EU MDR requirements.
• Regulatory Strategy: Contribute to regulatory strategy development to support product development and commercialization in the EU market.
• Quality Systems: Work closely with Quality Assurance to maintain compliance with Quality Management System (QMS) requirements.
• Labeling and Packaging: Ensure product labeling, packaging, and promotional materials meet EU regulatory standards.
• Audits and Inspections: Support internal and external audits, including notified body and regulatory authority inspections.
• Stakeholder Collaboration: Serve as a liaison between internal teams, regulatory agencies, and notified bodies.

Required Skills and Qualifications

• Education: Bachelor's degree in life sciences, biomedical engineering, pharmacy, or a related field. Advanced degrees preferred.
• Experience:
• Proven experience in regulatory affairs within the medical devices or pharmaceutical industry.
• Comprehensive understanding of EU MDR, including technical documentation, PMS, and vigilance requirements.
• Familiarity with other international regulations (e.g., FDA, ISO 13485).
• Technical Expertise:
• Knowledge of regulatory submission processes for CE marking.
• Experience with risk management (ISO 14971) and quality systems (ISO 13485).
• Proficiency in preparing and managing technical documentation.
• Analytical Skills: Strong ability to analyze regulatory guidelines and implement strategies for compliance.
• Communication: Excellent written and verbal communication skills for liaising with cross-functional teams, regulatory bodies, and notified bodies.
• Detail-Oriented: Exceptional attention to detail to ensure accuracy and compliance in documentation and processes.
• Project Management: Strong organizational and time management skills to handle multiple projects and deadlines effectively.
• Technical Tools: Proficiency in regulatory software tools and Microsoft Office Suite.

Preferred Qualifications

• Experience in clinical evaluation reporting (CER) under EU MDR.
• Certification in regulatory affairs (e.g., RAC) or equivalent.
• Familiarity with UDI implementation and EUDAMED database requirements.