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Sr. Counsel - Medical Devices (25-816)
IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.
Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.
Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.
The Opportunity: Senior Counsel – Medical Devices
This is a newly created, high‑visibility 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, post‑market 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 medical‑device 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 compliance‑related 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 software‑enabled technologies.
- Oversee data incident response and privacy‑by‑design 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 anti‑bribery and anti‑corruption 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 top‑level decisions.
- Innovation: Engage with cutting‑edge 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 mission‑driven organization committed to making the world better through light.
MA: $160,192 - $212,254
If interested in applying for this role please follow the link below:
https://myjobs.adp.com/ipgjobs/cx/job-details?__tx_annotation=false&reqId=5001168750806
Additional Info
Job Type : Full-Time
Education Level : Doctoral
Experience Level : Mid to Senior Level
Job Function : General