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Global Regulatory Affairs Specialist
2 months ago
International Regulatory Specialist (EU MDR) - Medical Device
Position Summary
The International Regulatory Specialist is tasked with ensuring adherence to EU regulatory standards and is responsible for overseeing the international regulatory submission framework.
Essential Qualifications:
Required - Minimum Qualifications:
Education: Bachelor's degree
Experience: At least 7 years of experience in international regulatory affairs
- Comprehensive understanding of the complete regulatory life cycle for medical devices across global markets.
- Proven track record of successful international regulatory submissions.
- Expertise in all facets of Regulatory Affairs, Submission Preparation, FDA and EU MDD/MDR 93/42/ECC Device Laws/Regulations, Worldwide Regulatory Requirements/Procedures, Project Management, and Negotiation.
Preferred Qualifications:
- Experience providing regulatory support for clinical trials involving medical devices.
- Strong interpersonal, analytical, and organizational skills, with the ability to navigate complex regulatory landscapes.
- Capacity to analyze and resolve non-standard regulatory challenges using independent judgment.
Key Responsibilities:
- Prepare intricate international regulatory submissions.
- Formulate international regulatory strategies.
- Offer insights on regulatory requirements, including presenting alternative solutions for compliance.
- Guide strategies and contingency plans regarding international regulatory obligations.
- Implement EU MDR for medical devices, leading to final EU certification and international deployment.
- Present program strategies and updates to senior management and stakeholders.
- Collaborate with IT and cross-functional teams to establish processes supporting EUDAMED activities.
- Provide strategic input and technical guidance on regulatory requirements for product modifications, considering international regulations.
- Draft technical documentation to support CE marking and other international submissions.
- Assist with international product registrations.
- Perform additional duties as assigned or required.
