Global Regulatory & Quality Counsel Lead (SaMD & AI)

Olympus Corporation; Boston (MA); Vor Ort; USD 200.000 - 230.000; Vollzeit

Zusammenfassung

Olympus Corporation in Massachusetts and Pennsylvania is seeking a Senior Director to provide strategic legal counsel on medical device regulatory and quality matters across the product lifecycle, including AI, SaMD, and digital health.

The role will independently manage significant legal projects, advise leadership on regulatory risks, support FDA and global authority interactions, and lead remediation programs and regulatory inspections. Travel up to 15% is anticipated.

Qualifikationen

• Juris Doctor Degree from an accredited law school.
• Minimum of 10 years of legal experience supporting FDA-regulated medical device companies.
• Experience counseling senior leadership on recalls, FDA inspections, Form 483s, Warning Letters, and enforcement actions.
• Experience leading or advising on complex remediation programs arising from regulatory findings.
• Experience supporting inspections and interactions with FDA and global regulatory authorities.

Aufgaben

• Strategic QARA Legal Support to Global Quality Assurance and Regulatory Affairs teams and business clients.
• Provide day-to-day legal counseling on regulatory and quality matters throughout the product lifecycle.
• Advise on regulatory submissions, certifications, licenses, and post-market surveillance.
• Support inspections, enforcement actions, and remediation strategies with global authorities.
• Draft guidance on policies, procedures, and governance documents related to quality systems.

Kenntnisse

Regulatory strategy

Regulatory affairs

Legal counsel

Cross-functional leadership

FDA inspections

Ausbildung

Juris Doctor Degree

Jobbeschreibung

Olympus Corporation in Massachusetts and Pennsylvania is seeking a Senior Director to provide strategic legal counsel on medical device regulatory and quality matters across the product lifecycle, including AI, SaMD, and digital health.

The role will independently manage significant legal projects, advise leadership on regulatory risks, support FDA and global authority interactions, and lead remediation programs and regulatory inspections. Travel up to 15% is anticipated.