Overview
A leading organization in the Business Services sector is seeking an Assistant General Counsel specializing in Regulatory Compliance. This role focuses on providing business-aligned legal guidance related to governance, compliance, and operational risk management. The position involves partnering with leadership, compliance stakeholders, and cross-functional teams to translate complex regulatory issues into practical recommendations that support responsible execution, improved decision-making, and sustainable growth.
Location: Remote (U.S. based candidates only, no visa sponsorship available)
Compensation: $250,000 – $275,000 annually
Responsibilities
- Provide legal counsel to Quality Assurance and Regulatory Affairs teams on product-related issues
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle
- Review and advise on promotional materials and product launch strategies for Sales and Marketing teams
- Monitor and provide guidance on evolving FDA and global medical device regulations
- Support post-market activities including adverse event reporting and regulatory inspections
Qualifications
- J.D. from an accredited law school with admission to practice in the relevant jurisdiction
- Extensive experience with FDA medical device regulations and product development processes
- Strong background in Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and FDA pre-market and post-market interactions
- Expertise in regulatory requirements for product promotional communications, labeling, and compliance
- Excellent analytical and communication skills
Preferred Skills and Experience
- Knowledge of FDA medical device regulations, Quality System Regulation (QSR), and ISO standards such as ISO 13485 and ISO 14971
- Experience with in vitro diagnostic (IVD) marketing strategies and clinical trial regulations
- Familiarity with post-market surveillance systems, adverse event reporting, and regulatory risk management tools
- Experience using compliance tracking software and product lifecycle management tools
- Previous experience working with medical device manufacturers
Benefits
- Comprehensive health care programs including medical, dental, and vision insurance
- 401(k) plan for eligible employees
- Paid time off to support work-life balance
- Remote work arrangement for flexibility
Equal Opportunity
The employer is an equal opportunity organization and encourages applications from candidates who may not meet every qualification but whose backgrounds could contribute to the team.