Senior Global Regulatory & Quality Counsel Director

Olympus America, Inc.; Westborough (MA); Hybrid; USD 210,000 - 334,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Employee Assistance Program

Wellbeing programs

Paid vacation & sick time

Parental leave

Holidays

On-site daycare

Café & Fitness center

Job summary

Olympus America, Inc. in Massachusetts and Pennsylvania is seeking a Senior Director, Regulatory & Quality Counsel, Global.

This role provides strategic legal support to global QA, regulatory affairs, and medical safety teams across product lifecycles, including SaMD and digital health. You will lead complex regulatory matters, interactions with FDA and global authorities, and remediation programs, while guiding cross‑functional teams in a fast‑paced, matrixed environment.

Qualifications

• Juris Doctor degree from an accredited law school.
• Minimum of 10 years of legal experience supporting FDA-regulated medical device companies.
• Experience advising senior leadership on global recalls and FDA inspections.
• Experience leading complex remediation programs arising from regulatory findings.
• Strong leadership, communication, and collaboration skills.

Responsibilities

• Provide strategic legal counsel to Global Quality Assurance and Regulatory Affairs teams and business clients, providing practical, risk-based legal advice on regulatory, quality, compliance, and enforcement matters.
• Support FDA and global regulatory clearances, approvals, registrations, licenses, and certifications necessary to market medical device products.
• Advise on remediation and quality-system improvement programs arising from FDA or other regulatory authority findings.
• Assist in inspection readiness, inspection management, and post-inspection response strategies.
• Oversee cross-functional regulatory and compliance initiatives in a global environment.

Skills

Regulatory law

FDA interactions

Leadership

Global compliance

Risk assessment

Education

Juris Doctor Degree from accredited law school

Job description

Olympus America, Inc. in Massachusetts and Pennsylvania is seeking a Senior Director, Regulatory & Quality Counsel, Global.

This role provides strategic legal support to global QA, regulatory affairs, and medical safety teams across product lifecycles, including SaMD and digital health. You will lead complex regulatory matters, interactions with FDA and global authorities, and remediation programs, while guiding cross‑functional teams in a fast‑paced, matrixed environment.