Sr Counsel - Medical - Marlborough, MA

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Job Summary:

The Senior Counsel for Medical Devices provides legal guidance and support to IPG's medical device division. This role is a key advisor across the organization, ensuring compliance with U.S. and global regulations, managing legal risk, overseeing contract accuracy, and handling corporate legal matters. This function will also uphold strong frameworks for regulatory compliance, commercial transactions, intellectual property, and data privacy.

Key Responsibilities:

Regulatory & Compliance Oversight

• Ensures ongoing compliance with FDA (21 CFR Part 820), MDR, ISO 13485, HIPAA, and other applicable global regulations.
• Partners with RA/QA on product submissions (510(k), PMA, CE Marking), labeling, advertising, audits, and inspections.
• Monitors and advises on regulatory changes impacting the business.
• Supports legal aspects of clinical trials, post-market surveillance, and cybersecurity compliance.

Corporate Governance & Transactions

• Advises on corporate governance, Board matters, and entity management.
• Drafts and negotiates contracts, including supplier, distributor, licensing, and joint venture agreements.
• Supports strategic initiatives such as M&A, partnerships, and global expansion.

Commercial & Contract Law

• Reviews and negotiates a broad range of commercial agreements (e.g., vendor, reseller, clinical trial, GPO).
• Ensures contract terms align with internal policies and applicable regulations.
• Supports research collaborations and industry partnerships.

Intellectual Property (IP) & Licensing

• Collaborates with R&D and IP counsel on patent strategies and IP protections.
• Manages licensing, technology transfers, and addresses infringement concerns.

Litigation & Risk Management

• Proactively identifies and mitigates legal risks across the medical device business functions.
• Leads internal investigations and coordinates with outside counsel on litigation or enforcement actions.
• Develops and implements risk mitigation and legal compliance strategies.

Employment & Labor Law

• Partners with HR on employment law matters as it pertains to compliance concerns with medical device employee infractions, such as quality and regulatory concerns.
• Ensures compliance with OSHA and other regulatory agencies.
• Provides legal guidance on applicable policies pertaining to medical device compliance.

Data Privacy & Cybersecurity

• Works directly with internal IT to support compliance with data protection laws (HIPAA, GDPR, CCPA).
• Oversees data incident responses, privacy policies, and training initiatives.

International Legal Considerations

• In strong partnership with Trade compliance, addresses global trade compliance challenges, including ITAR/EAR.
• Manages legal risks in international operations and supply chains.

Training & Policy Development

• Develops and delivers internal training on legal and compliance topics.
• Drafts and maintains internal policies as it pertains to the medical device business.

Qualifications:

• Juris Doctor (JD) from an accredited law school.
• Licensed to practice law and in good standing with at least one U.S. state bar.
• 8-12 years of legal experience, with a strong in-house experience in the medical device, pharmaceutical, life-sciences, or biotech sectors.
• Deep knowledge of FDA regulations, MDR, ISO 13485, HIPAA, and applicable global laws.
• Demonstrated experience in contract negotiation, IP, risk management, employment law, and data privacy.
• Demonstrated ability to manage complex legal matters independently and strategically.
• Ability to work cross-functionally within the legal team, ensuring alignment on legal strategies, consistency in guidance, and efficient collaboration across practice areas.

Exempt

MA: $160,192 - $212,254