Position Summary: The Legal Assistant will provide administrative and legal support to the legal team, contributing to the effective management of legal and regulatory matters, with a particular focus on medical devices and biologics. This role involves managing documentation, supporting compliance processes, and assisting with research on regulatory requirements in the healthcare and life sciences sectors. The ideal candidate will possess excellent organizational and communication skills, attention to detail, and a strong understanding of the legal and regulatory landscape in the medical devices or biologics industries.
Key Responsibilities: Administrative Support - Prepare, organize, and maintain legal documentation, including contracts, agreements, and regulatory filings.
- Schedule and coordinate meetings, conferences, and other legal team activities.
- Manage calendar and appointment scheduling for the legal team, including handling travel arrangements as needed.
- Assist with discovery requests, including reviewing requests, preparing and running document production, performing document searches, logging document collections, and performing document review.
Document Management - Review, draft, and format legal documents and correspondence under the guidance of attorneys.
- Organize and maintain both physical and electronic filing systems to ensure quick retrieval of information.
- Track contract renewal and expiration dates, alerting the legal team in advance of deadlines.
Compliance Support - Assist in gathering and organizing information for regulatory compliance filings with agencies such as the FDA or other global regulatory bodies.
- Work closely with the compliance team to support adherence to regulations related to medical devices, biologics, and healthcare.
Research and Analysis - Conduct legal research on various topics, including regulations, intellectual property, and product liability.
- Stay updated on relevant industry regulations and provide insights to the legal team as required.
- Summarize findings and provide recommendations based on research to help inform legal strategies.
Communication and Liaison - Serve as the point of contact for legal inquiries, providing information or redirecting requests as necessary.
- Collaborate with other departments, including Quality Assurance, Regulatory Affairs, and Product Development, to ensure legal compliance across functions.
- Communicate effectively with external stakeholders, such as outside counsel, vendors, and regulatory agencies.
Qualifications: - Associate's or Bachelor's degree in Legal Studies, Paralegal Studies, or a related field; paralegal certification is a plus.
- Minimum of 2-4 years of experience in a legal assistant or paralegal role, preferably in the healthcare, life sciences, medical device, or pharmaceutical industry.
- Familiarity with FDA regulations, healthcare compliance, and intellectual property considerations in the medical devices or biologics sectors.
- Strong organizational skills, with an ability to manage multiple priorities and meet deadlines.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and legal research tools (e.g., LexisNexis, Westlaw).
- Excellent written and verbal communication skills.
- High level of integrity and confidentiality when handling sensitive information.
Additional Preferred Qualifications: - Knowledge of product liability law, intellectual property law, and healthcare regulatory frameworks.
- Experience supporting legal teams with FDA or similar regulatory filings.
- Familiarity with document management software and contract lifecycle management systems.
Pay Range
$55,000-$65,000 USD
About Us Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies.
Our credentials Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange since 2016. With additional operations in the Netherlands and the USA, we continue to grow our global team. To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to reduce fusion failures.
- Listing on the SIX Swiss Exchange under the symbol KURN
- A commercial & research footprint that spans >20 markets
- 4 teams of internationally renowned clinical and scientific expert advisers
- >25 orthobiologics-related patents
- >400 patients evaluated in Level I, randomized controlled clinical trials
- 10 well-controlled Level I-III clinical trials initiated, including 6 that are complete*
Today, nearly 1 in 5 spinal fusions fail. But what can we do to change this situation - for the benefit of patients, surgeons, and our wider society? This is the question that drives us at Kuros. Every day our team works across three continents to unlock the hidden secrets of bone healing through our research, development & technology program: Project Fusion. To deliver the ideal bone graft, we believe you need the highest quality & quantity of scientific evidence behind it. Which is why Project Fusion brings together an unprecedented blend of scientific, pre-clinical and clinical studies - all aimed at making the unpredictable...predictable.
Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice here.