Working Location: Massachusetts, Westborough; Pennsylvania, Center Valley

Workplace Flexibility: Hybrid

Job Description

Senior Director, Regulatory & Quality Counsel, Global, reports to the VP, Regulatory & Quality Counsel, Global, and serves as a strategic legal partner to the Company's global Quality Assurance, Regulatory Affairs, and Medical Safety organizations. This role provides expert legal counsel on the full spectrum of medical device regulatory, quality, compliance, enforcement, and commercialization matters across the product lifecycle, including emerging technologies such as artificial intelligence (AI), software as a medical device (SaMD), digital health, and connected medical devices products.

Senior Director, Regulatory & Quality Counsel, Global will independently manage significant legal projects, advise leadership on complex regulatory risks, support interactions with FDA and global health authorities, lead legal support for regulatory inspections and enforcement actions, and provide strategic guidance on remediation programs, product development, commercialization, and global compliance initiatives. The role also provides leadership and oversight to other attorneys supporting the Global QARA organization.

This role covers multiple jurisdictions across the Americas, as well as other key business centers located in Japan, Europe, the Middle East and Africa, China, Asia Pacific.

Job Duties

• Strategic QARA Legal Support
  
  • Act as a strategic legal partner to Global Quality Assurance and Regulatory Affairs teams and business clients, providing practical, risk-based legal advice on regulatory, quality, compliance, and enforcement matters.
  • Provide day-to-day legal counseling to internal stakeholders on regulatory and quality matters affecting the development, manufacture, distribution, promotion, and post-market management of medical devices to support compliance with global medical device regulations.
• Global Regulatory Compliance
  
  • Counsel the business on all aspects of medical device regulation throughout the product lifecycle, including research and development, clinical activities, regulatory submissions, commercialization, post-market surveillance, quality systems compliance, and lifecycle management.
  • Assist business teams in obtaining FDA and other global regulatory clearances, approvals, registrations, licenses, and certifications necessary to market medical device products.
  • Support compliance with post-market regulatory requirements, including reporting obligations, field actions, recalls, and corrective actions.
  • Draft, review, and provide legal guidance regarding policies, procedures, quality system documentation, guidance documents, product manuals, training materials, and governance documents.
• Inspections, Enforcement, and Remediation
  
  • Advise the business regarding FDA inspections and inspections conducted by global regulatory authorities, including Notified Bodies, Health Canada, MHRA, PMDA, TGA, ANVISA, and other competent authorities.
  • Support inspection readiness activities, inspection management, inspector interactions, document production, escalation processes, and post-inspection response strategies.
  • Provide legal advice regarding inspectional observations (e.g., Form 483 observations), warning letters, import alerts, recalls, detentions and import restrictions, regulatory investigations, and other enforcement actions by FDA and global health authorities. Advise and assist in drafting responses to inspectional observations, regulatory inquiries, Warning Letters, and other enforcement communications.
  • Provide strategic legal oversight for remediation and quality-system improvement programs arising from FDA or other regulatory authority findings.
• Import and Export Compliance
  
  • Advise on FDA and global medical device import and export requirements. Provide legal support regarding import-for-export requirements, import alerts, detentions, product admissibility issues, global distribution and supply chain activities, and resolution of import restrictions and enforcement actions

Job Qualifications

Required:

• Juris Doctor Degree from accredited law school
• Minimum of 10 years of legal experience supporting FDA-regulated medical device companies.
• Combination of in-house counsel, law firm, and/or regulatory agency experience, including FDA experience.
• Significant experience advising medical device businesses on regulatory, quality, compliance, and enforcement matters.
• Demonstrated experience counseling senior leadership regarding global recalls, FDA inspections, Form 483 observations, Warning Letters, Import Alerts, and other enforcement actions.
• Experience leading or advising on complex remediation programs arising from FDA or other regulatory authority findings.
• Experience supporting inspections and interactions with FDA and global regulatory authorities.
• Experience advising on medical device import/export requirements and regulatory trade compliance issues.
• Experience managing complex cross-functional legal and compliance initiatives in a global environment.
• Deep expertise in medical device regulatory and quality law.
• Strong understanding of FDA medical device requirements and global regulatory frameworks.
• Strong understanding of enforcement trends and evolving regulatory requirements affecting digital health and AI-enabled medical devices.
• Excellent judgment and ability to provide practical, business-oriented legal advice in complex situations.
• Strong leadership, communication, negotiation, and collaboration skills.
• Proven ability to influence executive leadership and effectively manage multiple high-priority matters simultaneously.
• Ability to operate successfully in a fast-paced, highly regulated, global environment.
• Flexibility to work across global time zones, including early morning or evening calls in support of a large, global, matrixed organization.
• Travel up to 15% of time is anticipated.

Preferred:

• Experience supporting Class I, II, and III medical devices.
• Experience advising on Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), connected medical devices, digital health platforms, mobile medical applications, remote monitoring technologies, and AI/ML-enabled medical devices.
• Experience with EU MDR, UK MDR, ISO 13485, and other global medical device regulatory frameworks.
• Experience managing external regulatory counsel and consultants.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive medical, dental, vision coverage effective on start date
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance*
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

• Work-life integrated culture that supports an employee centric mindset
• Offers onsite, hybrid and field work environments
• Paid volunteering and charitable donation/match programs
• Employee Resource Groups
• Dedicated Training Resources and Learning & Development Programs
• Paid Educational Assistance

*US Only

**Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.

The anticipated base pay range for this full-time position in this location is $210,319.00 - $334,081.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.