Sr. Legal Counsel

Job SummaryProvide advice and counseling on a wide range of FDA regulatory and legal matters. Responsible for advising on complex regulatory issues, ensuring compliance, and minimizing legal risks related to FDA laws and regulations.Assist in managing litigation, government agency investigations, proactive training, and administrative charges.Job DescriptionResponsibilities:Provide legal counsel and advice on FDA regulatory matters, including product approvals (e.g. 510(k)), labeling, advertising, marketing, and post-market compliance.Advise on FDA-related legal issues in product development, manufacturing, distribution, FDA enforcement action, import, and promotion of pharmaceutical, medical device, and biotechnology products.Stay current with changes in FDA regulations, policies, and enforcement actions, ensuring the company’s operations remain compliant.Develop and implement regulatory strategies to support the company’s business objectives while ensuring legal compliance.Assist in interactions with the FDA, including responding to FDA inquiries, submitting regulatory filings, and participating in meetings or negotiations.Provide guidance on global regulatory issues in coordination with international legal and regulatory teams.Work with outside counsel as needed for complex or specialized regulatory matters.Qualifications:Juris Doctor degree.Member of a state bar in good standing.At least 4 years of experience providing FDA related legal counsel at a law firm or corporation.Experience developing legal strategy and tactics for complex, high profile matters.Experience providing legal advice to senior executives and other senior leaders.Preferred Qualifications:Experience diagnosing, isolating, and resolving complex issues and recommending and implementing strategies to resolve problems.Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems.Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.Position requires travel up to 20% of the time for business purposes (within state and out of state).

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