Staff Regulatory Affairs Specialist Job at Catalyst Life Sciences, San Diego, CA

RzNvYm1GdUh3Rm9RMkZDdG9FWTZOb0pBVmc9PQ==
  • Catalyst Life Sciences
  • San Diego, CA

Job Description

Opportunity to join a global diagnostics company's Regulatory Affairs team, to be the SME and lead all regulatory activities for one of the organization's most exciting product lines.

Responsibilities

  • Lead multiple long-term projects, collaborating with management on key issues including regulatory applications, EU-IVDR submissions, and renewals across global markets, ensuring compliance with applicable rules and regulations. Oversee technical documentation and export certificates.
  • Review and approve product labeling for regulatory compliance, including format, content, and registration impacts.
  • Maintain current knowledge of evolving regulations, emerging standards, and scientific issues in relevant geographies.
  • Develop strategies to comply with new regulations and collaborate with subject matter experts.

Experience Required

  • 6 years' Regulatory Affairs experience within life sciences, with 4 years in the IVD space submitting 510(k)s and/or IVDR technical documentation.
  • Bachelor’s degree in a life science, engineering, or equivalent required. Advanced degree preferred.
  • Ability and willingness to work onsite in Mira Mesa.

Job Tags

Similar Jobs

Prowinch LLC

Project Manager Assistant - Trilingual (English / Spanish / Italian) Job at Prowinch LLC

 ...Project Manager Assistant Trilingual (English / Spanish / Italian) Location: Miami, FL Full-time position Company Overview: We are an international company specializing in industrial lifting equipment (hoists, winches, cranes, and control systems), with active... 

SEMCO ENERGY

Propane Delivery Driver Job at SEMCO ENERGY

 ...Join Our Team Bulk Delivery Driver (Full-Time) at SEMCO Energy! Looking for a stable, hands-on career in propane delivery? SEMCO Energy is hiring a Bulk Propane Delivery Driver for our Hot Flame location in Carney, MI and we want you on board! What Youll Do:... 

Ulike Global

Creative Director(Art Base) Job at Ulike Global

Ulike is seeking an international Brand Creative Director to lead a wide variety of creative projects for the US and EU markets, including online video and graphic ad campaigns, offline activation designs, and brand guidelines development. You must be hands-on and...

US Tech Solutions

Network Engineer Job at US Tech Solutions

 ...Position Summary: Client is seeking a Telecom Data Network Engineer in support of ongoing and emerging work across the Midwest region network. This position requires a solid understanding of routing and switching and a general understanding of wireless and firewall technologies... 

Boca Prep International School

College/Guidance Counselor Job at Boca Prep International School

 ...Boca Prep International School is seeking a College/Guidance Counselor to join our team. The ideal candidate should be someone who prioritizes the overall well-being and social-emotional nature of every student while promoting the development of young people to contribute...