Senior Regulatory Affairs Specialist

Location

San Diego, California, US

Job Type

Permanent

Company Overview

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

You will have post-market regulatory responsibilities for all LumiraDx COVID (SARS-CoV-2) in vitro diagnostic products. You will also assume responsibilities for establishing and maintaining FDA compliance for the portfolio of marketed LumiraDx products.
Key responsibilities:
In accordance with EUA requirements, will proactively identify and complete regulatory duties such as:
  • 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.

Required Experience

About you:
You will be an experienced and motivated Regulatory Affairs professional with the following attributes:
  • 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

APPLY

Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process for employment or continued employment to comply with legal and regulatory obligations to which the company is subject. LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security.