Program Manager, CQR

VB Spine

$145K — $155K *
Healthcare
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Deep knowledge of global medical device regulations, focusing on FDA CFR, MDSAP, and EU MDR requirements
  • Experience working with a globally distributed cross-functional team
  • Direct experience with Notified Bodies and Competent Authorities
  • Bachelor's degree in management, engineering, sciences, quality, regulatory, or a related discipline
  • PMP certification or equivalent preferred
  • Minimum of 8 years of project/program management experience
  • Experience in the medical device industry
  • Strong interpersonal communication and negotiation skills
  • Proficiency with project management tools like MS Office and SharePoint
  • Ability to lead teams through change and ambiguity

Responsibilities

  • Create and maintain program documentation to support business goals and objectives
  • Coordinate with partners and users to identify opportunities and deliver solutions
  • Own program budget estimation and monitoring
  • Communicate expectations across various teams and stakeholders
  • Maintain program risk assessments to track and mitigate risks
  • Lead resource planning to effectively allocate workload and capacity
  • Monitor cost, schedule, and performance of projects for overall success

Benefits

  • Comprehensive health, dental, and vision insurance
  • 401(k) with company match
  • Paid time off (PTO) and holidays
  • Ongoing training and professional development opportunities
  • Opportunity to grow within a fast-paced, dynamic company
Full Job Description
Program Manager, CQR
Location: Remote (15-20% Travel Required)

Company: VB Spine

As a Program Manager, CQR in our Clinical Quality & Regulatory (CQR) function, you'll provide leadership and direction for medium-complexity programs, ensuring successful delivery from initiation through completion while aligning with broader organizational goals and PMOs.

What You'll Do:

  • 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

What You Bring:

  • Deep Knowledge of global medical device regulations iwth focus on FDA CFR, MDSAP, and EU MDR requirements.
  • Experience in working with a globally distributed cross functional team.
  • Direct experience in working directly with Notified Bodies and Competent Authorities.
  • Bachelor's degree (BA/BS) or equivalent (emphasis in management, engineering, sciences, quality, regulatory, or related discipline preferred)
  • PMP certification or equivalent desired
  • Minimum of 8 years of demonstrated project/program management experience
  • Experience in the medical device industry
  • Excellent interpersonal communication, collaborative teamwork, conflict management, and negotiation skills
  • Ability to build trusting relationships with mid-level management and present proposals to executives
  • Demonstrated ability to mentor, train, and develop team members
  • Strong proficiency with project management tools (PPM systems, MS Office, SharePoint, Visio, etc.)
  • Versatility and willingness to lead teams through change and ambiguity

Compensation:
Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $145,000.00 - $155,000.00 annually (or local market equivalent), with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, location, and market conditions.

Benefits include:

  • Comprehensive health, dental, and vision insurance
  • 401(k) with company match (or local equivalent)
  • Paid time off (PTO) and holidays
  • Ongoing training and professional development opportunities
  • Opportunity to grow within a fast-paced, dynamic company

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