Hybrid Senior Director, Global Compliance & Strategy

Dassault Systèmes; New York (NY); Hybrid; USD 158,000 - 210,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Life insurance

Disability insurance

401(k) matching

Family leave

Flexible PTO

Paid holidays

Job summary

Medidata seeks a Senior Director, Global Compliance & Strategy to shape regulatory affairs across its life sciences technology platform. You will partner with product, engineering and leadership to translate complex regulations into scalable policies and design controls.

The role leads a team of compliance professionals, monitors global regulatory developments, and guides horizon scanning to pre-empt changes affecting the platform and roadmap.

Qualifications

• 10+ years of experience in regulatory affairs and/or quality management in life sciences.
• Experience managing internal teams of compliance professionals.
• Ability to communicate strategy at the executive/board level.
• Expertise in FDA, ICH guidelines and global frameworks.

Responsibilities

• Serve as trusted advisor to executive leadership on regulatory risk and compliance decisions.
• Own regulatory strategy for healthcare tech products across US and Europe.
• Lead QMS ownership, risk management, and validation activities.

Skills

Regulatory affairs

Quality management

Executive communication

FDA/ICH knowledge

Tools

QMS tools

Job description

Medidata seeks a Senior Director, Global Compliance & Strategy to shape regulatory affairs across its life sciences technology platform. You will partner with product, engineering and leadership to translate complex regulations into scalable policies and design controls.

The role leads a team of compliance professionals, monitors global regulatory developments, and guides horizon scanning to pre-empt changes affecting the platform and roadmap.