Global Regulatory Director, Medical Devices & Strategy

Paylocity; Bedford (MA); On-site; USD 215,000 - 230,000; Full time

Job summary

Spryte Medical seeks a Director of Regulatory Affairs to guide global regulatory strategy for a portfolio of neurovascular imaging devices. You will lead cross‑functional teams, manage complex submissions, and oversee external regulators to accelerate market access.

The role emphasizes building a high‑performing Regulatory Affairs function and ensuring ongoing compliance. The ideal candidate has 12+ years in medical device regulatory affairs, with 3–5 years in leadership and proven success with

Qualifications

• Bachelor's degree in a technical or life sciences field required.
• 12+ years in regulatory affairs within medical devices.
• 3–5 years of regulatory leadership with cross‑functional teams.
• Experience leading FDA regulatory submissions (IDE, De Novo, PMA, 510(k)).
• Knowledge of EU MDR and international frameworks.

Responsibilities

• Lead global regulatory strategies across product development and lifecycle.
• Serve as regulatory lead with cross‑functional teams and executives.
• Own complex submissions to FDA, EU Notified Bodies, and other authorities.
• Build and scale the Regulatory Affairs organization.
• Ensure compliance across design controls, labeling, and post‑market activities.

Education

Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related discipline

Advanced degree (MS, MPH, MBA, PhD, or equivalent)

Job description

Spryte Medical seeks a Director of Regulatory Affairs to guide global regulatory strategy for a portfolio of neurovascular imaging devices. You will lead cross‑functional teams, manage complex submissions, and oversee external regulators to accelerate market access.

The role emphasizes building a high‑performing Regulatory Affairs function and ensuring ongoing compliance. The ideal candidate has 12+ years in medical device regulatory affairs, with 3–5 years in leadership and proven success with