Clini Experts Regulatory Partner is a leading consultancy specializing in regulatory compliance for pharmaceuticals and medical devices. We assist companies in navigating complex FDA, EU MDR, and global regulatory frameworks, ensuring seamless product approvals and market access.
Join our dynamic team and contribute to life-saving innovations in the medical device industry!
Job Description: Executive Regulatory Affairs (Medical Device)
Key Responsibilities:
✔ Regulatory Documentation: Prepare checklists for MD 3, MD 4, MD 7, MD 8, MD 12, MD 14, MD 16, MD 22, MD 26, MD 28 as per MDR 2017 & other guidelines.
✔ License Management: Handle applications for Test License, Manufacturing License, Import License, and new device permissions.
✔ Post-Approval Compliance: Manage post-submission changes, variations, and renewals.
✔ Regulatory Strategy: Ensure compliance with EU MDR, FDA, and other global regulations.
✔ Stakeholder Coordination: Liaise with health authorities, manufacturers, and testing labs.
Eligibility & Qualifications
✅ Education: Bachelor’s in Life Sciences, Pharmacy, Biology, or related field (Master’s preferred).
✅ Experience: Minimum 2 years in Medical Device Regulatory Affairs.
✅ Skills Required:
- Strong knowledge of MDR 2017, ISO 13485, FDA 21 CFR.
- Expertise in technical documentation & submissions.
- Excellent communication & project management skills.
Benefits of Joining Clini Experts
🔹 Competitive salary & performance bonuses
🔹 Flexible work options (Hybrid/Remote)
🔹 Career growth in global regulatory affairs
🔹 Continuous learning & certification support
How to Apply
📩 Send your updated CV to: career@cliniexperts.com
📌 Subject Line: “Application for Executive Regulatory Affairs – Medical Device”
