Regulatory Affairs Specialist
5 days ago
Trueline's client, a leading international law firm, is seeking a highly skilled Regulatory Affairs Specialist to join their esteemed FDA Medical Device and Technology practice team in Denver. This is an exciting opportunity to be part of a prestigious firm and work on cutting-edge regulatory matters.
Key Responsibilities:
- Provide support to lawyers during the entire state licensing submission process, from initial client information-gathering to final submission and regulatory review
- Assist with analysis of state licensing requirements, correspondence with regulatory agencies, coordinating acquisition and archiving of licensure materials
- Perform submission assembly, complete state application forms, and manage projects
- Assist in creating tools, resources, and marketing collateral related to regulatory matters
- Conduct research on changes to state licensure laws and other regulatory topics as needed
- Support the team with additional tasks as required, under attorney supervision
Requirements:
- Minimum 3 years of relevant experience, preferably from a large law firm
- Strong knowledge of regulations and working with regulatory bodies
- Expertise in Microsoft Office suite, Adobe, and/or Nuance software
- Exceptional attention to detail and organizational skills
- Ability to work efficiently in a fast-paced environment
- Excellent written and verbal communication abilities
- J.D. from an ABA-accredited law school and an active bar membership
What We Offer:
- Potential for discretionary or hours-based bonus
- Comprehensive benefits including health insurance, retirement plans, etc.
- Opportunity to work at a prestigious international law firm
- Exposure to cutting-edge regulatory matters in the medical device industry
Trueline and its clients are equal opportunity employers committed to diversity and inclusion. We encourage all qualified applicants to apply, regardless of race, color, gender, religion, national origin, ancestry, citizenship, disability, age, sexual orientation, or other protected characteristics.
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