Senior Regulatory Affairs Specialist
San Diego, California, US
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
- Adverse event monitoring and reporting
- Distribution of EUA products
- Product administration
- Advertising and promotional material compliance
- Maintain all EUA records in a highly organized matter
- Document and maintain records of all FDA communications
- Provide information to FDA in a timely manner
- Work collaboratively with internal project teams and stakeholders to proactively manage details related to the EUA products.
- Prepare and present regular updates to management and key stakeholders.
- Minimum of a Bachelor’s degree in a medical, scientific, or technical discipline. An advanced degree is highly preferred.
- Formal training in regulatory affairs with RAC certification highly desirable.
- A minimum of 6+ years of increasing responsibility in medical device regulatory affairs; experience with diagnostic devices highly preferred but not required. Comparable experience in pharma or biologics will be considered if individual demonstrates the ability to transfer skills and knowledge.
- Experience with Emergency Use Authorization (EUA) or Humanitarian Use Exemption (HUE) is highly preferred, but not required.
- Highly proficient with Microsoft Office, database tools, and telecommunication tools.
- Excellent written and oral communication skills.
- Highly organized with strong attention to detail.
- Ability to work in a complex, face-paced environment.
- Action-oriented and attentive to deadlines
For further information and to apply for this role, please click APPLY