Medical Device Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Medical Device Senior Regulatory Affairs Specialist for a remote position.

Key Responsibilities:

• Collaborate with internal and external stakeholders to define and clarify regulatory requirements and workflows
• Monitor and evaluate global regulatory environment and identify changes that impact the company platform
• Provide regulatory knowledge and training to internal and external customers

Required Qualifications:

• Bachelor's degree
• 5+ years of MedTech regulatory affairs experience
• Experience authoring regulatory submissions for product approval
• Excellent working knowledge of global MedTech regulations
• Ability to function effectively in a self-directed environment and take a leading role within the department or with cross-functional teams