Regulatory Counsel (Sales & Marketing), Medical Devices

Medical device company seeks Regulatory Counsel to support sales and marketing activities.  Position will be the primary attorney handling these matters in the legal department.

Duties:

• Facilitate the business objectives of the company by providing practical, timely and effective legal support, while minimizing potential legal risks

• Provide high quality guidance and support to the company’s regulatory and quality assurance teams and business units on healthcare and medical device regulatory matters

• FDA regulatory matters

• Advertising and promotion

• Healthcare fraud and abuse

• Antitrust (such as tying arranagements)

• Anti-corruption

• Implement policies and procedures

• Coordinate cross functional, regional teams

• Oversee compliance monitoring (in partnership with the Compliance Department)

• Assess risks and establish metrics for effectiveness

• Work in close cooperation with Compliance Department, including participation in investigations when required

• Develop a thorough understanding of and familiarity with: the company’s business, its people, products, markets, facilities, customers and competitors and use this knowledge in providing guidance and counsel

• Identify training needs and assist in development and presentation of training and education regarding regulatory requirements and developments

• Perform special assignments or projects if necessary

Required:

• JD

• Licensed and admitted to practice law in good standing in at least one U.S. state

• At least 7 years of experience in private practice, in-house counsel and/or government (FDA)

• Demonstrated experience in FDA regulatory law

• Experience with US device marketing, advertising and promotion regulations

• Ability to analyze and interpret efficacy and safety data

• Decision-making ability and experience

• Problem solver—able to find practical solutions and provide practical guidance

• Accountable and hands-on, self-starter, results oriented

• Desire to understand products and business

• Able to gain the trust of and form solid relationships with various business clients and Legal Department colleagues

• Able to manage multiple high-priority projects simultaneously

Desired Experience:

• At least 2-3 years as in-house counsel in medical device or pharmaceutical industry

• General understanding of medical device regulation outside of the U.S.