Sr Manager, Global Regulatory Counsel

Company Overview

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

This Legal Counsel role will function as a key member of Insulet Corporation's Legal team and reports to the Vice President, Global Regulatory Counsel. The ideal candidate is a highly collaborative and experienced commercial/regulatory attorney who has a proven track record of being successful and valued working as a partner with business clients in an in-house setting, preferably within the life sciences industry. He or she must possess excellent legal and business judgment and must be able to demonstrate success balancing the need to limit risk to the company with the goal of supporting the creativity, enthusiasm, and pace of internal clients as we grow the company together. The candidate must be able to work independently but collaboratively within a fast-paced, high-performance environment, providing legal advice and guidance related to a wide range of commercial contracts and other business matters. The role will also support other business needs and large-scale special projects, as needed.

Responsibilities

• Legal Advisory. Responsible for providing solution and business-oriented legal advice, support, counsel, representation, and services to the commercial/regulatory functional areas of the company, including Quality, Regulatory, Clinical/Medical Affairs, Post-Market, Compliance, Marketing, Sales, and Managed Care/Market Access.
• Marketing. Manage labeling and marketing review of Direct-to-Consumer (DTC) and HCP marketing materials. Responsible for developing our global marketing strategy and competitive positioning, while also monitoring and responding to competitive challenges and regulatory agency inquiries. The ability to anticipate and influence regulatory agency enforcement action is essential.
• Contract Management. Draft, review, negotiate, and provide guidance on a wide variety of agreements and documents including purchase agreements, software licensing agreements, non-disclosure agreements, lease agreements, and contractor/vendor terms ensuring both legal and business objectives are met. Experience with rebate agreements and similar agreements for the sale and distribution of pharmaceutical products is a plus.
• Risk Management. Work closely with the business teams to understand the needs and strategic objectives of the company to provide high quality, pragmatic, and focused legal advice and assist in growing the company's global business.
• Process Improvement. Work with colleagues to continuously improve contract structure and processes as well as implementation and adherence to best practices within both the Legal department and the company.
• Monitoring Changes. Track and identify changes in relevant laws, regulations, and industry standards that affect the medical device industry in countries the company operates, and support modifying company strategies accordingly.
• Miscellaneous. Performs other duties as assigned.

Key Decision Rights

• Contractual Agreements. Decision-making authority on the review, negotiation, and finalization for a wide variety of contracts.
• Risk Assessment. Ability to issue spot, evaluate potential legal risks and implement appropriate risk mitigation strategies.
• Policy Implementation. Authority to help develop, implement, and enforce company-wide legal policies and procedures.
• Power to liaise directly with internal and external parties as necessary and appropriate.

Required Leadership/Interpersonal Skills & Behaviors

• Exceptional interpersonal and communication skills.
• Highest

standards of integrity and good judgment.

• Proven

capacity to influence, build trust, work independently and collaboratively, and engage and collaborate effectively at all levels of the company.

• Proven

strong problem resolution skills and ability to multitask, prioritize and respond to emerging issues effectively in a challenging, fast-paced environment.

Required Skills And Competencies

• Ability to juggle competing priorities in a corporate environment while remaining a valued and respected member of business teams.
• Ability

to quickly identify potential issues/problems and to escalate to applicable stakeholders when needed.

The ability to leverage his/her business judgment and legal skills to help close important business deals and establish or strengthen strategic partnerships.

• Proven experience solving both practical and multi-variable problems and challenges, with excellent risk-based judgment.

Education And Experience

• Law degree from an accredited law school/university e.g. JD, LLB or equivalent.
• 3-6 years of broad-based legal experience in relevant areas including regulatory, commercial contracting and compliance work, specifically with notified bodies and European regulatory agencies, European directives and regulations.
• Experience with a medical device or life sciences company is preferred. Experience

in either a major law firm or in-house in a corporate legal department.

Additional Information

• The position is hybrid at our London, UK or the Utrecht, Netherlands office.

Travel is estimated up to 10%, but will flex depending on business needs.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit and

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

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