Regulatory Counsel

Legal St. Paul, Minnesota


Description

This position is responsible for identifying and helping minimize risks by delivering proactive legal support services that promote business development and regulatory compliance through practical solutions. This individual will provide legal advice, counsel and services on a wide range of legal matters, primarily focusing on compliance with applicable laws and regulations applicable to a medical device company. This position provides first-line legal support to the Regulatory, Marketing, Quality, Clinical and Medical Affairs departments.

Essential Duties and Responsibilities:
• Identify and analyze legal issues and present clear recommendations.
• Provide counsel on regulatory matters, with particular emphasis on the Food, Drug and Cosmetic Act, FDA regulations, FTC laws and regulations, and the Sunshine Act.
• Advise and actively participate in the development of procedures, practices and systems that ensure compliance with regulatory requirements.
• Advise on the development, revision, review and approval of claims on labels and advertisements and other promotional materials.
• Advise on matters relating to interactions with healthcare providers and institutions.
• Assist in managing and responding to regulatory agency investigations and audits and administrative actions.
• Research various non-U.S. laws and regulations, both existing and proposed, affecting international regulatory matters; formulate and provide appropriate legal guidance.
• Advise the Clinical Affairs Department on the development and execution of clinical trials, including the development of trial protocols and the development and negotiation of Clinical Trial Agreements.
• Review proposed policies, procedures and standards and provide legal assessments and recommendations.
• Monitor and track proposed regulations that could impact the company’s business.
• Assist with transactions such as mergers, acquisitions, strategic investments and collaborative development projects.
• Advise on general legal, regulatory and compliance matters with respect to ongoing business activities.
• Assess potential liability risks to company and provide legal advice in connection therewith.
• Manage and provide oversight to outside counsel.
• Participate on teams or internal corporate activities beyond specific legal area of responsibility, such as process improvements and policy formation.
• Other duties designated by the General Counsel or Associate General Counsel from time to time.
Knowledge, Skills and Abilities Required for Successful Job Performance:

Minimum Qualifications:
• Degree from an accredited law school of recognized standing
• License to practice law in Minnesota
• 5+ years of relevant legal experience in a corporate law department and/or private practice
• Experience advising on advertising and promotional matters in the medical device industry
• Demonstrated ability and desire to work collaboratively in a team environment

Knowledge, Skills and Abilities Required for Successful Job Performance:
• Familiarity with laws, regulations and rules of the Food and Drug Administration and those relating to false claims, anti-kickback, and other relevant compliance areas
• Polished professional, poised executive presence and excellent presentation, interpersonal, and diplomacy skills
• Strong interpersonal communication skills, including change management; conflict resolution and listening; ability to manage a variety of constituencies at all levels; accurate and persuasive written and verbal communication skills; and proven negotiation skills
• Action-oriented ability to identify and implement opportunities
• Proven ability to influence change and build collaboration within an organization, and among a complex set of clients and stakeholders with varying needs
• Ability to manage multiple matters and collaborate cross-functionally throughout the organization

Other critical personal traits include the following:
• Highly ethical
• Excellent negotiating and advocacy skills
• Excellent written and verbal communications skills
• Self-confidence with the courage of his/her convictions
• Excellent relationship-building skills
• Self-motivated, independent self-starter
• Impeccable, discerning listening skills
• Strong intuitive skills - ability to quickly and accurately assess people and situations
• Trusted, respected and recognized as having integrity
• Places a high value on treating others with dignity and respect

Specifications/Other
Regular office environment; require the ability to sit, stand and work at a desk
Physical abilities (must be able to lift 50 lbs)
Mental abilities (able to look at computer screen 8 hours per day)

CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600.