Remote Global Compliance & Vendor Risk Leader

Medisca; Austin (TX); À distance; USD 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

PTO & holidays

Group health plan

401k plan

Career growth opportunities

Employee referral program

Company events

Résumé du poste

Medisca is seeking a Compliance Manager to lead regulatory initiatives across global jurisdictions, including FDA, Health Canada, EMA and TGA. The role focuses on vendor programs, risk assessment, and cross-functional collaboration to ensure quality and compliance in a fast-paced environment.

Ideal candidate has extensive regulatory knowledge, strong project management skills, and the ability to implement strategic regulatory plans globally while mentoring the compliance team.

Qualifications

• Bachelor's degree in a science-related field required.
• Minimum 5–7 years in a managerial role in Quality, Compliance or Regulatory Affairs (total 10+ years).
• Knowledge of FDA, Health Canada, TGA and EMA regulations.
• Experience in project management and cross-functional coordination.
• Proficient in Microsoft Office; Creatio and MasterControl a plus.

Responsabilités

• Lead and oversee global regulatory compliance initiatives.
• Coordinate vendor qualification and qualification audits.
• Develop regulatory strategies for go-to-market in Europe and other regions.
• Design and deliver compliance training to cross-functional teams.
• Collaborate with QA, Supply Chain, Legal and IT to ensure compliant processes.
• Monitor and report on KPIs and risk mitigation plans.
• Maintain licenses and registrations; ensure SOPs align with regulations.

Connaissances

Regulatory leadership

Project management

Cross-functional collaboration

Writing skills

Risk assessment

Formation

Bachelor's degree in a Science related field

Outils

Microsoft Office Suite

Creatio

MasterControl

Description du poste

Medisca is seeking a Compliance Manager to lead regulatory initiatives across global jurisdictions, including FDA, Health Canada, EMA and TGA. The role focuses on vendor programs, risk assessment, and cross-functional collaboration to ensure quality and compliance in a fast-paced environment.

Ideal candidate has extensive regulatory knowledge, strong project management skills, and the ability to implement strategic regulatory plans globally while mentoring the compliance team.