Career Opportunities

Legal Counsel II FDA

Posted on: Thursday, July 9, 2015
Organization: Medtronic, Inc.
Location: Minneapolis, MN
Description:

Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with 85,000+ employees in more than 160 countries.

POSITION DESCRIPTION

This position could reside in Minneapolis, MN or Washington D.C.

This individual will be part of a corporate, shared-service team of lawyers that combines deep substantive expertise in regulatory areas core to Medtronic’s business with in-house understanding of Medtronic’s businesses. Team members work across business units and geographies resulting in unique ability to 1) advise businesses on complex legal regulatory questions, 2) identify common and conflicting legal issues and positions across the company, and 3) contribute to high-level policy decision-making. This position reports to the Senior Legal Director- FDA/Corporate Legal Regulatory.

POSITION RESPONSIBILITIES

Responsibilities for this position include:
• Acting as strategic legal partner for the Medtronic businesses in substantive legal areas on issues of government regulation and enforcement while serving on a strong Corporate-level team of in-house FDA lawyers.
• Advising Medtronic Corporate and Business Unit Legal, Quality, Regulatory, Clinical and other functions on substantive issues related to regulatory authority inspections and associated communications with regulators.
• Advising Medtronic Corporate and Business Unit Legal, Regulatory and other functions on advertising and promotion issues.
• Advising Medtronic Corporate and Business Unit functions on policies, procedures and risk mitigation practices associated with off-label use.
• Advising Corporate and Business Unit functions on recalls, corrections and removals, and other regulatory authority requirements related to post-market product performance.
• Partnering with Medtronic Corporate and Business Unit Quality, Regulatory & Clinical Affairs functions to develop policies, procedures, legal guidance documents, tools and training materials.
• Conducting and/or providing legal support to colleagues on compliance investigations that include allegations related to quality, regulatory, or clinical matters.
• Identifying and driving mitigation of risks that cross Medtronic businesses and facilitating information sharing across and among Medtronic businesses.
• Assisting M&A team with due diligence in substantive areas.
• Providing litigation support relating to FDA issues in Medtronic businesses.
• Monitoring the external regulatory and enforcement environment to identify emerging risks to the company.
• Developing expertise and applying knowledge in discrete areas of state and/or federal regulation (e.g. state and federal licensing requirements) as they pertain to Medtronic products and businesses.

 

Requirements:

IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING
BASIC QUALIFICATIONSMUST BE EVIDENT ON YOUR RESUME:

EDUCATION REQUIRED:
• Juris Doctor from nationally recognized Law School

YEARS OF EXPERIENCE:
• 5+ years of legal experience, particularly in Drug or Device Law

SPECIALIZED KNOWLEDGE/SKILLS REQUIRED:
• Experience in counseling on quality compliance
• Experience in counseling on advertising and promotion

DESIRED/PREFERRED QUALIFICATIONS

• Ability to establish credibility and develop strong working relationships with clients
• Capable of and experienced in effectively working in groups and with senior management
• An understanding of business objectives, strategies and relevant tactics
• Seasoned professional with good professional judgment
• Exceptional oral and written communications skills
• Strong team skills
• Experience in counseling medical device or pharmaceutical industry clients in the area of quality compliance and enforcement as it has been applied to the pharmaceutical and medical device industries
• Experience in advising on promotion of medical devices

PHYSICAL JOB REQUIREMENTS

• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
• Travel is varied (up to 25%) and will be primarily to Medtronic facilities to provide on-site support as needed

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