Senior Director, Regulatory Affairs

A company is looking for a Senior Director, Regulatory Combination Product.

Key Responsibilities

Develop comprehensive strategies for biologic and device components aligned with corporate goals and regulatory expectations

Provide guidance on compatibility studies, design verification, and usability testing while contributing to risk assessments

Lead interactions with health authorities and manage device-related regulatory information in company systems

Required Qualifications

A bachelor's degree in a scientific or engineering discipline

Experience as a regulatory lead in pharmaceutical, biotechnology, or medical device industries, especially with combination product filings

Strong knowledge of regulations and standards related to combination products in global clinical studies

Proven track record in late-stage development of combination products

In-depth understanding of ISO and ASTM standards relevant to combination products