Sr. Legal Counsel-FDA

Job Summary

Provide 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 Description

Responsibilities:

• 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).

Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.