Remote Program Manager, Medical Device Regulatory & Quality

VB Spine, LLC; Allendale (NJ); Remote; USD 145,000 - 155,000; Full time

Benefits offered by this job

Comprehensive health, dental, and view

401(k) with company match

Paid time off (PTO) and holidays

Ongoing training and professional dev

Growth opportunities

Job summary

VB Spine is seeking a Program Manager, CQR to lead medium-complexity programs within Clinical Quality & Regulatory. This remote role with 15-20% travel requires coordinating with global teams, Notified Bodies, and healthcare regulators to ensure timely, compliant delivery from initiation through completion.

The ideal candidate brings extensive medical device project management experience, deep regulatory knowledge (FDA CFR, MDSAP, EU MDR), and proven ability to mentor teams, manage budgets, and

Qualifications

• Deep knowledge of global medical device regulations including FDA CFR, MDSAP, and EU MDR requirements.
• Minimum 8 years of demonstrated project/program management experience in the medical device industry.

Responsibilities

• Create and maintain program documentation (charters, roadmaps, benefits maps, etc.) to support business goals and program objectives.
• Coordinate with partners and end users to deliver value through opportunity identification, solution delivery, and ongoing support.
• Own program budget estimation, monitoring, and attainment.
• Communicate and set expectations across divisions, functions, third-party vendors, consulting partners, project teams, and stakeholders, including Notified Bodies and Competent Authorities.
• Create and maintain program risk assessments to identify, track, and close risks.
• Lead portfolio resource planning, including workload allocation and capacity planning to sequence projects effectively.
• Work with project managers and associates to monitor cost, schedule, and technical performance of component projects while ensuring overall program success.
• Assess trade-offs for changes in project scope, schedule, and costs that impact the broader program.
• Improve team performance by building cohesiveness, leading, influencing, training, mentoring, and motivating team members.
• Serve as an escalation point and drive collaboration to resolve conflicts, issues, and deviations.
• May manage project managers and project personnel, as well as lead indirect resources.

Skills

Regulatory knowledge

Cross-functional collaboration

Stakeholder management

Mentoring

Budgeting

Education

Bachelor’s degree or equivalent

Tools

PPM systems

MS Office

SharePoint

Visio

Job description

VB Spine is seeking a Program Manager, CQR to lead medium-complexity programs within Clinical Quality & Regulatory. This remote role with 15-20% travel requires coordinating with global teams, Notified Bodies, and healthcare regulators to ensure timely, compliant delivery from initiation through completion.

The ideal candidate brings extensive medical device project management experience, deep regulatory knowledge (FDA CFR, MDSAP, EU MDR), and proven ability to mentor teams, manage budgets, and