Careers


Associate Attorney - Regulatory

Reports to: Senior Attorney

Industry: Law Practice (FDA-regulated industry)

Employment Type: Full-time

Location: Flexible (office located in Stillwater, MN)

Licensure: Unrestricted license to practice law in a U.S. state

Preferred License: Admission to any federal district court

Level: Mid-level

Exempt Status: Exempt

Hours of Work: Varies

Travel Required: Yes (minimal, e.g., <5%)

Date posted: January 25, 2024

Qualifications, (E) = essential to job, (P) = preferred:

  • 2+ years of experience working in industry at a medical device, pharmaceutical, biologic, or diagnostic company, e.g., working in Legal, Regulatory Affairs, Quality Affairs, Clinical Affairs, Product Management, R&D, or a related role. (E) 
  • Experience with FDA regulatory matters, including medical device submissions, regulatory strategy, and advertising and promotion review and processes. 
  • Possess medical device submission (e.g., 510(k), PMA, IDE, De Novo, EUA) and advertising and promotion review knowledge. (E) 
  • Knowledge of health care laws and regulations (e.g., Food, Drug and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), False Claims Act (FCA), and Physician Payments Sunshine Act (PPSA)). (E) 
  • Demonstrates ability to lead projects. (E) 
  • Responsive, persistent, and capable of managing numerous assignments and responsibilities simultaneously in a dynamic and fast-paced environment while meeting goals and deadlines. (E) 
  • Flexible, independent, and self-starting. (E) 
  • Collaborative, business-minded, and not combative. (E) 
  • Ability to work productively with individuals with opposing viewpoints and strong personalities, including company lawyers, executives, and regulators. (E) 
  • Exceptional attention to detail. (E) 
  • Ability to write and speak in an effective, persuasive, and concise manner. (E) 
  • Ability to analyze disparate information quickly and design effective and practical solutions to problems. (E) 
  • Bachelor of Arts or Bachelor of Science. (E) 
  • Juris Doctor (or equivalent) from an ABA-approved law school. (E) 
  • Licensed and in good standing to practice law in a U.S. state. (E) 
  • Strong grasp of and attention to ethics laws and the Model Rules of Professional Conduct. (E) 
  • Advanced degrees, licenses, certifications favored, e.g., MD, MBA, PhD, MSc, MPH, RAC, CPA. (P)

Primary functions:

  • Making FDA regulatory submissions (e.g., 510(k), PMA, IDE, De Novo, EUA). 
  • Anti-fraud and FDA compliance review of promotional materials and commercial programs.
  • Drafting opinions regarding compliance with various laws including: FDCA, AKS, FCA, PPSA, HIPAA, among others. 
  • FDA meetings. 
  • Performing research. 
  • Serving on promotional material and scientific material review teams. 
  • Advising clients on compliant interactions with health care professionals.

Benefits:

  • Flexible work environment.
  • Highly competitive compensation package.
  • Opportunity to be a part of a high-performing distinguished team.
  • Mentoring and coaching opportunities (giving and receiving).
  • Firm commitment to work-life balance, health, and well-being.
  • Medical, disability and life insurance benefits.
  • Bonus program.
  • 401(k) match.
  • Open vacation.
  • Tuition assistance for work-related certifications and training.
  • Trail-blazing best-in-class clientele.

Words our employees use to describe Gardner Law:

  • Rewarding.
  • Good work/life balance.
  • Variety in work and clientele.
  • Collaborative.
  • Flexible.
  • Independent.
  • Fast-paced.
  • Impactful.
  • Focused on FDA-regulated industry.
  • Opportunity for growth and advancement.

Send resume and cover letter outlining how you fit the role along with examples of demonstrated leadership abilities to Tracy Erickson, MAcc, C.P.A., CFO & COO at terickson@gardner.law.

About Gardner Law

Gardner Law is an FDA law firm that specializes in regulatory, compliance and privacy. Saving patients’ lives and improving people’s health is our purpose at Gardner Law and it guides everything we d

Associate Attorney - Privacy

Reports to: Senior Attorney

Industry: Law Practice (FDA-regulated industry)

Employment Type: Full-time

Location: Flexible (office located in Stillwater, MN)

Licensure: Unrestricted license to practice law in a U.S. state

Preferred License: Admission to any federal district court

Level: Mid-level

Exempt Status: Exempt

Hours of Work: Varies

Travel Required: Yes (minimal, e.g., <5%)

Date posted: January 25, 2024

Qualifications, (E) = essential to job, (P) = preferred:

  • 2+ years of experience working in industry at a medical device, pharmaceutical, biologic, or diagnostic company, e.g., working in Legal, Regulatory Affairs, Quality Affairs, Clinical Affairs, Product Management, R&D, or a related role. (E) 
  • Knowledge of privacy laws and regulations (e.g., HIPAA, HITECH, GDPR, CCPA, CAN-SPAM, TCPA, and FTC) (E) 
  • Knowledge of health care laws and regulations (e.g., Food, Drug and Cosmetic Act (FDCA), Anti-Kickback Statute (AKS), False Claims Act (FCA), and Physician Payments Sunshine Act (PPSA)). (E) 
  • Demonstrates ability to lead projects. (E) 
  • Responsive, persistent, and capable of managing numerous assignments and responsibilities simultaneously in a dynamic and fast-paced environment while meeting goals and deadlines. (E) 
  • Flexible, independent, and self-starting. (E) 
  • Collaborative, business-minded, and not combative. (E) 
  • Ability to work productively with individuals with opposing viewpoints and strong personalities, including company lawyers, executives, and regulators. (E) 
  • Exceptional attention to detail. (E) 
  • Ability to write and speak in an effective, persuasive, and concise manner. (E) 
  • Ability to analyze disparate information quickly and design effective and practical solutions to problems. (E) 
  • Bachelor of Arts or Bachelor of Science. (E) 
  • Juris Doctor (or equivalent) from an ABA-approved law school. (E) 
  • Licensed and in good standing to practice law in a U.S. state. (E) 
  • Strong grasp of and attention to ethics laws and the Model Rules of Professional Conduct. (E) 
  • Advanced degrees, licenses, certifications favored, e.g., MD, MBA, PhD, MSc, MPH, RAC, CPA. (P)

Primary functions:

  • Reviewing for compliance with privacy and cybersecurity requirements, including HIPAA, HITECH, FTCA, GDPR, CCPA, CAN-SPAM, TCPA and other laws 
  • Designing, drafting, implementing, and reviewing privacy policies and procedures 
  • Evaluating marketing programs for privacy compliance
  • Reviewing and negotiating business associate agreements, data processing agreements, privacy clauses, standard contractual clauses, and other privacy agreements 
  • Auditing privacy and cybersecurity programs including inquiries based on standards such as ISO 27001, NIST, and others 
  • Assisting manufacturers building HIPAA compliance programs as a business associate or covered entity 
  • Performing privacy officer or data protection officer services on a contract basis 
  • Privacy training for organizations including general privacy matters, as well as case coverage and complaint handling 
  • Reviewing and evaluating products, applications and websites for privacy compliance, including contact forms, opt-in consents, privacy policies 
  • Drafting patient authorizations and consents 
  • Supporting privacy and security incident matters 
  • Assisting manufacturers with clinical trials, including data transfer agreements, transfer impact assessments, informed consent, privacy notices, and advice on use of patient data 
  • Assessing the application of privacy requirements with mandated FDA reporting and data collection 
  • Reviewing commercial field activities for privacy compliance

Benefits:

  • Flexible work environment.
  • Highly competitive compensation package.
  • Opportunity to be a part of a high-performing distinguished team.
  • Mentoring and coaching opportunities (giving and receiving).
  • Firm commitment to work-life balance, health, and well-being.
  • Medical, disability and life insurance benefits.
  • Bonus program.
  • 401(k) match.
  • Open vacation.
  • Tuition assistance for work-related certifications and training.
  • Trail-blazing best-in-class clientele.

Words our employees use to describe Gardner Law:

  • Rewarding.
  • Good work/life balance.
  • Variety in work and clientele.
  • Collaborative.
  • Flexible.
  • Independent.
  • Fast-paced.
  • Impactful.
  • Focused on FDA-regulated industry.
  • Opportunity for growth and advancement.

Send resume and cover letter outlining how you fit the role along with examples of demonstrated leadership abilities to Tracy Erickson, MAcc, C.P.A., CFO & COO at terickson@gardner.law.

About Gardner Law

Gardner Law is an FDA law firm that specializes in regulatory, compliance and privacy. Saving patients’ lives and improving people’s health is our purpose at Gardner Law and it guides everything we d

Controller

Reports to: CFO/COO

Industry: Finance/Accounting/Administration/Operations

Employment Type: Full-time

Location: Flexible (office located in Stillwater, MN)

Licensure: CPA preferred (inactive)

Level: Minimum five years experience as controller, law firm experience preferred

Exempt Status: Exempt

Hours of Work: Varies

Travel Required: Yes (minimal, e.g., <5%)

Date posted: January 15, 2024

Primary functions:

  • Responsible for managing the daily financial operations of the firm including accounts receivable and payables, payroll, general ledger, account reconciliations, incentive plans and budgets.
  • Work with outside CPAs to ensure correct accounting practices are in effect. Prepare all financial information necessary for outside CPAs to prepare our year-end tax forms. Prepare ad hoc financial reports when requested.
  • In charge of the firm's Office 365 network, QuickBooks accounting system and Clio billing system, as well as client systems that Gardner Law inputs data into. Point of contact for website and IT issues in house, consult with outside IT consultants for resolution where necessary and appropriate.
  • Recruit, interview, and facilitate the hiring of qualified job applicants for open positions. Work with attorneys to understand skills and competencies required for role openings. Implement new hire orientation and employee onboarding. Facilitate employee development planning and programming.
  • Develop and maintain firm human resources policies and procedures in accordance with federal, state, and local laws. Ensure that all changes are implemented and communicated appropriately after approval.
  • In charge of our annual benefits open enrollment which requires prior review of all benefits plans inclusive of medical, dental, life, and disability plans. Responsible for maintaining the firm’s 401k plan, ensuring all new employees are enrolled in a timely manner and the firm follows Internal Revenue Service and Department of Labor laws.
  • Assist office manager with the operations of the facility. Negotiate lease terms as needed.
  • Complete annual application for professional liability and other insurance renewals.
  • Must be prepared and willing to take on additional law firm administrator responsibilities as they arise.

The ideal candidate should possess a proven track record in office management and the ability to review and improve our current administrative processes. This role is a starting point for a distinguished professional looking to play a major leadership role in a cutting edge law firm that caters to advanced FDA-regulated companies advancing the state of the art in medical technology, pharmaceutical, food, and laboratory sciences. 

Benefits:

  • Flexible work environment.
  • Highly competitive compensation package.
  • Opportunity to be a part of a high-performing distinguished team.
  • Mentoring and coaching opportunities (giving and receiving).
  • Firm commitment to work-life balance, health, and well-being.
  • Medical, disability and life insurance benefits.
  • Bonus program.
  • 401(k) match.
  • Open vacation.
  • Tuition assistance for work-related certifications and training.
  • Trail-blazing best-in-class clientele.

Words our employees use to describe Gardner Law:

  • Rewarding.
  • Good work/life balance.
  • Variety in work and clientele.
  • Collaborative.
  • Flexible.
  • Independent.
  • Fast-paced.
  • Impactful.
  • Focused on FDA-regulated industry.
  • Opportunity for growth and advancement.

Send resume and cover letter outlining how you fit the role along with examples of demonstrated leadership abilities to Tracy Erickson, MAcc, C.P.A., CFO & COO at terickson@gardner.law.

About Gardner Law

Gardner Law is an FDA law firm that specializes in regulatory, compliance and privacy. Saving patients’ lives and improving people’s health is our purpose at Gardner Law and it guides everything we d