Senior Regulatory Affairs Manager (Onsite)

CorDx is seeking a Senior Regulatory Affairs Manager to lead and manage regulatory submissions for medical device products, including 510(k) and De Novo submissions. This role involves ensuring compliance with regulations, providing guidance to cross-functional teams, and contributing to the successful approval and launch of innovative medical devices. The company focuses on driving innovation in global health.

Requirements

• Prepare, review, and submit regulatory documents to FDA.
• Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
• Ensure that all products comply with applicable regulatory requirements.
• Provide regulatory guidance to R&D team during product development life cycle.
• Stay updated on changes in regulatory requirements and communicate potential impacts to the organization.
• Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways.
• Collaborate with internal stakeholders and external partners to ensure alignment on regulatory strategies and project timelines.

Benefits

• Highly competitive compensation package
• Comprehensive medical, dental, and vision insurance
• 401(k) plan with generous company contributions
• Flexible paid time off (PTO) policy
• Additional substantial benefits