Senior Legal Counsel

The Coloplast North America Legal team advises leaders and employees across multiple business units—Chronic Care (Continence, Ostomy, Bowel Management), Wound & Tissue Repair/Kerecis, Interventional Urology, Voice & Respiratory Care/Atos, and Durable Medical Equipment providers (Comfort Medical)—on a wide variety of legal issues and matters involving multiple substantive areas of law. The team provides counsel, guidance, legal and contract support, and strategic business partnership in a highly regulated environment spanning the medical device and medical supply service (Durable Medical Equipment) industries.

The Senior Legal Counsel serves as the primary legal adviser for assigned businesses and substantive areas within North America. As a legal generalist and subject‑matter expert, the counsel applies extensive legal expertise to collaborate with functional experts and stakeholders, ensuring material legal issues are quickly identified, communicated to senior management with clear recommendations, and efficiently resolved.

Major Areas of Accountability

• Serve as legal counsel and advisor to leaders at VP, Director levels and their teams.
• Provide legal advice, guidance and support to business clients in assigned areas.
• Proactively communicate legal matters and projects to leaders and stakeholders, influencing decision‑making.
• Collaborate with Compliance to assess and advise the business on operational practices, establishing policies and procedures.
• Advise other functions on policies and practices.
• Identify gaps and opportunities for improvement, assisting implementation.
• Participate in business projects to advance legal and business objectives.
• Assess legal risks across assigned business areas, developing risk‑mitigation strategies in collaboration with business, Compliance and support functions.
• Independently liaise with external third parties (competitors, distributors, customers, outside counsel) regarding legal claims, promotional issues, best practices and contract negotiations.
• Manage and direct efforts of outside counsel.
• Prepare, review, and negotiate a wide variety of contracts and agreements for assigned business areas, including supply, distribution, insurance, GPO; product sales, rebate, marketing, clinical, research, vendor, employment and other agreements.
• Review and advise on medical device promotional materials.
• Advise on marketing and physician relations programs, and patient education initiatives.
• Provide sound, practical legal guidance and solutions in ambiguous and undefined situations.
• Identify, create and implement best practices for contract preparation and negotiation.
• Ensure all employees conduct business to the highest ethical and professional standards and comply with applicable laws, regulations and company policies.
• Other job duties as assigned.

Basic Qualifications

• Juris Doctorate from a U.S. accredited law school.
• Licensed attorney in the U.S., admitted to at least one jurisdiction; if not licensed in Minnesota, must be able to obtain a Minnesota House‑Counsel license.
• Minimum 8–10 years of legal experience as a practicing attorney.
• Working knowledge of the medical device industry and specific legal issues applicable to a U.S. medical device business.
• Working knowledge of HIPAA and the U.S. privacy law landscape.
• Experience negotiating and drafting complex commercial contracts.
• Previous in‑house experience preferred.
• Experience providing legal or compliance support for a medical device or pharmaceutical company.
• Experience in promotional issues and materials, commercial sales of medical devices or pharmaceuticals, AKS/FCA, FDA regulatory issues, and clinical issues.
• Ability to travel up to 10% of the time.

Competencies

• Ability to analyze complex legal and business issues.
• Effective written and oral legal argumentation.
• Effective communication of complex facts and laws.
• Demonstrated multi‑tasking and prioritization skills.
• Proactive, flexible, responsive and resourceful.
• Ability to work independently and collaboratively in a small team.
• Excellent legal and business judgment in decision‑making.
• Strong negotiation and contract drafting skills.
• Strong stakeholder management skills.
• Proficient knowledge in at least five of the following legal areas:
  • Anti‑kickback statute
  • False claims act
  • HIPAA and privacy issues
  • FDA and regulatory law regarding medical devices and pharmaceuticals
  • Clinical trials
  • Reimbursement issues
  • Medical device/pharmaceutical marketing & promotional issues
  • Discount safe harbor and related laws in medical device sales
  • Medical device/pharmaceutical compliance issues

Skills

• Exceptional written and oral communication skills for all internal and external audiences.
• Work product presentation instills confidence in quality.

Benefits

• Health and Wellness: comprehensive medical, dental, and vision insurance, wellness programs, mental health resources, paid leave for qualifying events, and generous paid parental leave.
• Financial Security: competitive 401(k) with company match, financial planning services, and corporate discount programs.
• Work‑Life Balance: generous paid time off, flexible hours and arrangements.
• Professional Development: continuous learning, mentorship, and tuition reimbursement.
• Recognition and Rewards: peer recognition, bonuses, awards, and special events.
• Community and Culture: supportive environment, team building, volunteer opportunities, and sustainability initiatives.
• Competitive Compensation: salary range $156,000–$234,000; additional bonuses/incentives may apply.

Coloplast employees are required to conduct business to the highest ethical and professional standards and comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) and does not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or status with regards to public assistance.

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