Global Compliance & Strategy Director — Hybrid NYC

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

Benefits offered by this job

Medical insurance

Dental insurance

Life insurance

Disability insurance

401(k) matching

Family leave

Flexible paid time off

10 paid holidays

Job summary

Medidata, based in New York, seeks a Senior Director of Global Compliance & Strategy to shape regulatory affairs and quality systems across its life sciences technology platform. The role sits at the intersection of product, compliance and internal strategy, translating rules into executable frameworks for the business.

You will lead the maintenance of the QMS, monitor FDA/ICH guidance, and support engineering with design controls and risk management.

Qualifications

• 10+ years in regulatory affairs and/or quality management in life sciences.
• Experience managing an internal compliance/regulatory affairs team.
• Strategy development at executive or board level.
• Expertise in FDA, ICH guidelines and global regulatory frameworks.
• Experience managing a QMS.
• Advising product and engineering teams on regulatory requirements and risk.

Responsibilities

• Advise executive leadership on regulatory risk and compliance decisions.
• Own regulatory strategy for healthcare tech across US/Europe.
• Lead horizon scanning of regulatory developments and guidance.

Skills

Regulatory strategy

Executive engagement

Regulatory affairs

Quality management

Leadership

Regulatory analysis

AI governance

Job description

Medidata, based in New York, seeks a Senior Director of Global Compliance & Strategy to shape regulatory affairs and quality systems across its life sciences technology platform. The role sits at the intersection of product, compliance and internal strategy, translating rules into executable frameworks for the business.

You will lead the maintenance of the QMS, monitor FDA/ICH guidance, and support engineering with design controls and risk management.