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Global Regulatory Affairs Specialist
2 months ago
International Regulatory Specialist (EU MDR) - Medical Device
Role Summary:
The International Regulatory Specialist is tasked with ensuring adherence to EU regulatory standards and oversees the comprehensive international regulatory submission process.
Essential Qualifications:
Required - Minimum Qualifications:
Education: Bachelor's degree
Experience: At least 7 years in international regulatory affairs
- Extensive knowledge of the complete regulatory life cycle for medical devices across various international 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, Global 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 scenarios.
- Capability to assess and resolve unique regulatory challenges using independent judgment.
Key Responsibilities:
- Develop intricate international regulatory submissions.
- Formulate international regulatory strategies.
- Offer insights on regulatory requirements, including alternative approaches to compliance.
- Guide on strategies and contingency planning regarding international regulatory obligations.
- Implement EU MDR for medical devices, facilitating the final stages for 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 that support EUDAMED activities.
- Provide strategic input and technical advice on regulatory requirements for product modifications, considering global regulations.
- Prepare technical documentation to support CE marking and other international submissions.
- Assist with international product registrations.
- Perform additional duties as assigned or required.
