Sr Counsel – Medical – Marlborough, MA

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About IPG Photonics

IPG Photonics is the global leader in highperformance fiber laser technology, pioneering solutions that transform industries and improve lives. With more than 4,800 employees across 30+ locations worldwide, we develop advanced laser systems that power breakthroughs in manufacturing, healthcare, communications, and cleanenergy applications.

At IPG, our purpose is simple but ambitious: applying light in ways that improve life. That mission drives our innovation, our culture, and the talent we seek to attract.

About IPG Medical

IPG Medical, a wholly owned subsidiary of IPG Photonics, is dedicated to bringing nextgeneration laser technologies to the medical device industry. Based in Marlborough, MA, we are building cuttingedge systems that enable safer, more effective, and more accessible clinical care worldwide.

As we expand our medical portfolio and accelerate our growth, we are creating key roles that shape the future of our organization – including this newly created Senior Counsel position.

The Opportunity: Senior Counsel – Medical Devices

This is a newly created, highvisibility role that reports directly to the SVP, General Counsel & Corporate Secretary of IPG Photonics.

As Senior Counsel, you will serve as the primary legal advisor for IPG’s medical device business, guiding the organization through complex regulatory environments, commercial strategy, and global expansion. You’ll collaborate closely with senior leaders, R&D teams, product innovators, and global functions to ensure our growth is both legally sound and aligned with our mission.

What You’ll Do

Regulatory & Compliance Leadership

• Serve as the principal advisor on FDA QSR (21 CFR Part 820), 510(k), PMA, EU MDR, ISO 13485, HIPAA, and global regulatory frameworks.
• Partner with RA/QA teams on submissions, labeling, audits, inspections, and corrective actions.
• Support clinical research programs, postmarket surveillance, adverse event reporting, and device cybersecurity.

Commercial & Transactional Partnership

• Draft, review, and negotiate commercial agreements including supplier, OEM, distributor, licensing, and GPO contracts.
• Ensure commercial activities align with medicaldevice regulatory requirements.
• Support M&A evaluations, strategic partnerships, and global expansion initiatives.

Intellectual Property & Innovation Support

• Collaborate with R&D and IP counsel on patents, trademarks, and licensing.
• Advise on product claims, marketing materials, and competitive positioning.

Risk Management, Investigations & Governance

• Identify and mitigate legal risks across the product lifecycle.
• Lead internal investigations and coordinate litigation strategy when needed.
• Provide legal support for crisis management, field actions, and recalls.

Employment, Safety & Compliance Culture

• Partner with HR on compliancerelated employment matters.
• Support workplace safety and OSHA obligations.
• Develop and deliver training on compliance, ethics, and policy expectations.

Data Privacy & Cybersecurity

• Advise on HIPAA, GDPR, CCPA/CPRA and global privacy requirements.
• Support cybersecurity programs for connected devices and softwareenabled technologies.
• Oversee data incident response and privacybydesign practices.

International Legal & Trade Compliance

• Work with Trade Compliance on EAR, sanctions, and import/export controls.
• Evaluate distributor and supplier risks across international markets.
• Ensure compliance with antibribery and anticorruption laws including FCPA and UK Bribery Act.

Why Join IPG Medical?

• Impact: Your work will directly support technologies that improve patient outcomes.
• Visibility: Reporting to the SVP, General Counsel & Corporate Secretary, your insights influence toplevel decisions.
• Innovation: Engage with cuttingedge photonics and medical device technologies.
• Growth: As a newly created role, you will shape the legal foundation of a rapidly expanding business.
• Purpose: Contribute to a missiondriven organization committed to making the world better through light.

What You Bring

• Juris Doctor (JD) and active membership in at least one U.S. state bar.
• 8-12+ years of legal experience, ideally inhouse with a medical device or life sciences company.
• Deep expertise in FDA regulations, EU MDR, ISO 13485, HIPAA, and global compliance frameworks.
• Strong commercial contracting experience and ability to support complex transactions.
• Skill in advising R&D, engineering, and product teams.
• Excellent communication skills with the ability to influence at all levels.
• A practical, strategic mindset paired with uncompromising integrity.

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