Global Compliance Leader — Regulatory & Vendor Programs

Medisca; United States; Remote; USD 110,000 - 170,000; Full time

Benefits offered by this job

PTO and holidays

Health benefits

401(k) plan

Employee referral program

Company events

Career growth opportunities

Job summary

Medisca seeks a Compliance Manager to lead global regulatory compliance initiatives, including vendor qualification programs and regulatory strategy for go-to-market in Europe. You will partner with Quality, Regulatory, Operations, IT and Product Management to ensure adherence to FDA, Health Canada, EMA, and TGA standards.

The role requires strong project management, cross-functional collaboration, and the ability to mentor staff while driving KPIs.

Qualifications

• Bachelor's degree in a Science related field required.
• 5–7 years in managerial role in Quality, Compliance or Regulatory Affairs with total 10 years experience.
• Knowledge of FDA, Health Canada, TGA and EMA regulations.
• Experience with vendor management and global regulatory programs.
• Proficient with MS Office; prior experience with Creatio or MasterControl is an asset.

Responsibilities

• Plan, lead and manage compliance initiatives across global jurisdictions.
• Communicate risks and mitigation strategies to stakeholders.
• Develop detailed project plans, timelines and resources to meet compliance goals.
• Collaborate with QA, Regulatory, Operations, IT and Product Management to ensure cross-functional alignment.
• Lead meetings, provide status updates and monitor milestones.
• Oversee vendor qualification and onboarding processes with audits and assessments.

Skills

Regulatory knowledge

Project management

Microsoft Office

Vendor management

Education

Bachelor's degree in a Science related field

Tools

Creatio

MasterControl

GxP systems

Job description

Medisca seeks a Compliance Manager to lead global regulatory compliance initiatives, including vendor qualification programs and regulatory strategy for go-to-market in Europe. You will partner with Quality, Regulatory, Operations, IT and Product Management to ensure adherence to FDA, Health Canada, EMA, and TGA standards.

The role requires strong project management, cross-functional collaboration, and the ability to mentor staff while driving KPIs.