Senior Director, Regulatory and Quality Counsel, Global

Job overview

Senior Director, Regulatory and Quality Counsel, Global is a hybrid role with listed work locations in Westborough, MA, and Center Valley, PA. The stated annual base salary range is $210,319–$334,081, plus potential annual bonus. Olympus advances medical technologies and works with healthcare professionals to improve patient outcomes. The role provides strategic legal counsel to global Quality Assurance, Regulatory Affairs, and Medical Safety organizations across medical-device product lifecycles. It advises leaders on regulatory and quality risks, supports health-authority interactions and enforcement matters, and guides compliance and remediation initiatives across global operations.

What you'll do

• Provide risk-based legal advice on regulatory, quality, compliance, and enforcement matters
• counsel on medical-device lifecycle requirements and regulatory submissions
• support post-market reporting, recalls, and corrective actions
• review policies and quality-system documents
• advise on inspections and enforcement actions
• support inspection readiness and responses
• oversee remediation programs
• and advise on import and export compliance.

What we're looking for

Skills & competencies

senior director

regulatory counsel

quality counsel

medical devices

fda compliance

global regulatory affairs

quality assurance

legal

hybrid

westborough ma

center valley pa

up to 15% travel

$210,319–$334,081/year

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision coverage
• 401(k) company match
• employee assistance program
• wellbeing programs
• paid vacation and sick time
• paid parental leave and adoption assistance
• 12 paid holidays
• onsite childcare, café, and fitness center
• paid volunteering
• training and educational assistance.

Why this role

Hybrid role covering multiple jurisdictions across the Americas and other key business centers; anticipated travel up to 15%.

About the employer

Olympus Corporation of the Americas is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.