Regulatory Affairs Director — Diagnostics (Remote)

Castle Biosciences, Inc.; Friendswood (TX); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Bonus potential

PTO and holidays

401K match

Health plan options

Stock grant

Job summary

Castle Biosciences Inc. seeks an Executive Director, Regulatory Affairs to shape regulatory strategy for diagnostics and devices. You will lead submissions, lifecycle management, and cross‑functional alignment with executives, steering compliance across US and international markets.

The role requires 10+ years in regulatory affairs, 3+ years in leadership, and strong interactions with the C‑suite; remote work is considered, with travel up to 25% as needed.

Qualifications

• Bachelor's degree or higher in a related field; extensive regulatory affairs background.
• Minimum 10+ years in regulatory affairs within medical devices or diagnostics.
• 3+ years in a management role with regulatory staff oversight.

Responsibilities

• Lead regulatory strategy for US and international submissions and lifecycle management.
• Partner with executives and cross-functional teams to ensure compliance and product timelines.
• Direct interactions with C-suite and Board on regulatory matters.

Skills

Bachelor's Degree

10+ years regulatory affairs

3+ years management

C-suite interaction

Regulatory guidelines

Lab diagnostics experience

Education

Bachelor's Degree or higher

Job description

Castle Biosciences Inc. seeks an Executive Director, Regulatory Affairs to shape regulatory strategy for diagnostics and devices. You will lead submissions, lifecycle management, and cross‑functional alignment with executives, steering compliance across US and international markets.

The role requires 10+ years in regulatory affairs, 3+ years in leadership, and strong interactions with the C‑suite; remote work is considered, with travel up to 25% as needed.