Senior Regulatory Affairs Specialist - Remote Spine Devices

VB Spine, LLC; Leesburg (VA); On-site; USD 100,000 - 105,000; Full time

Job summary

VB Spine Leesburg, VA is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for US, EU, and global markets, ensuring timely approvals for spinal devices and ongoing compliance across sections of regulatory documentation.

You will collaborate with cross-functional teams, prepare and manage regulatory submissions such as 510(k)s, and coordinate with FDA and other Health Authorities while guiding junior staff in a fast-paced medical device environment.

Qualifications

• Minimum 2+ years of Regulatory Affairs experience in FDA-regulated medical device industry.
• Hands-on experience preparing and submitting 510(k)s and/or Technical Documentation.
• Working knowledge of US and EU medical device regulations; international experience a plus.
• RAC certification desirable.

Responsibilities

• Participate on cross-functional product development teams to ensure regulatory requirements are incorporated.
• Author and manage regulatory submissions (510(k)s, Technical Documentation) to secure approvals.
• Communicate FDA feedback to project teams and leadership.
• Support post-market submissions, progress and annual reports.
• Advise teams on regulatory pathways to market.
• Interface with FDA and other regulatory agencies on submissions and compliance.

Skills

Regulatory Affairs

510(k) submissions

FDA regulations

Leadership

Project management

US/EU medical devices

RAC (desirable)

Scientific regulatory principles

Education

Bachelor’s degree in a scientific area

Job description

VB Spine Leesburg, VA is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategies for US, EU, and global markets, ensuring timely approvals for spinal devices and ongoing compliance across sections of regulatory documentation.

You will collaborate with cross-functional teams, prepare and manage regulatory submissions such as 510(k)s, and coordinate with FDA and other Health Authorities while guiding junior staff in a fast-paced medical device environment.