Remote Program Manager - Clinical Quality & Regulatory

VB Spine; Allendale (NJ); On-site; USD 145,000 - 155,000; Full time

Benefits offered by this job

Health, dental, vision insurance

401(k) with company match

PTO and holidays

Training and development opportunities

Growth opportunities

Job summary

VB Spine is seeking a Program Manager, CQR, to lead medium-complexity programs within Clinical Quality & Regulatory. The role is remote with 15-20% travel and involves directing documentation, budgeting, risk management, and cross-functional collaboration with Notified Bodies and regulatory authorities.

Ideal candidates have 8+ years in project/program management within the medical device industry, solid regulatory knowledge (FDA CFR, MDSAP, EU MDR), and proven leadership across global teams.

Qualifications

• Bachelor’s degree or equivalent in a relevant field.
• 8+ years proven project/program management experience.
• Experience in the medical device industry and regulatory environments.
• Experience interacting with Notified Bodies and Competent Authorities.
• Strong communication and stakeholder management skills.

Responsibilities

• Create and maintain program documentation (charters, roadmaps, benefits maps).
• Coordinate with partners and end users to deliver value and identify opportunities.
• Own program budget estimation, monitoring, and attainment.
• Communicate across divisions, vendors, and authorities including Notified Bodies.
• Create and maintain program risk assessments and track risks.
• Lead portfolio resource planning and capacity planning.
• Monitor cost, schedule, and technical performance of component projects.
• Assess trade-offs in scope, schedule, and costs.

Skills

FDA CFR

MDSAP

EU MDR

Regulatory knowledge

Cross-functional teamwork

Notified Bodies experience

Global collaboration

Project leadership

Education

BA/BS or equivalent

Tools

PPM tools

MS Office

SharePoint

Visio

Job description

VB Spine is seeking a Program Manager, CQR, to lead medium-complexity programs within Clinical Quality & Regulatory. The role is remote with 15-20% travel and involves directing documentation, budgeting, risk management, and cross-functional collaboration with Notified Bodies and regulatory authorities.

Ideal candidates have 8+ years in project/program management within the medical device industry, solid regulatory knowledge (FDA CFR, MDSAP, EU MDR), and proven leadership across global teams.