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

VlF3MGZuS3QxSHlVM1ErQWp5VVR5NHFXQ0E9PQ==
  • 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

Level One Personnel

Pharmacist Job at Level One Personnel

 ...Job Description Job Description Hybrid Pharmacist (HIV/AIDS Specialist) Location: Elkridge, MD Hours: 8...  ...pre-determined, there is some flexibility on remote work Monday-Thursday. All staff works from home on Fridays. Pay: $60/hour+ (negotiable based on... 

American Policy Ventures

Government Relations Associate Job at American Policy Ventures

Join to apply for the Government Relations Associate role at American Policy VenturesJoin to...  ...role in taking APVs impact to the next level.We are open-minded about the experience...  ...travel.Seniority level Seniority level Entry levelEmployment type Employment type Full... 

Fathom Plumbing Solutions

Journeyman Plumber (Lead Tech) Job at Fathom Plumbing Solutions

 ...tradesmen. Your Role: What You'll Do Handle service calls for residential and light commercial plumbing Diagnose, repair, and install all kinds of plumbing systems Use ServiceTitan to manage your jobs and earn bonuses through smart upsells Work independently... 

Matrix Providers

Nurse Practitioner NP / Physician Assistant PA Job at Matrix Providers

 ...to our Veterans at the Medical Disability Examinations ( MDE) facility in Chamberlain, SD. Matrix Providers is hiring a Nurse Practitioner (NP) or Physician Assistant (PA) to join our team of talented medical professionals to conduct one-time, non-treatment Veteran... 

Infojini Inc

Public Relations Manager Job at Infojini Inc

 ...Location- Albany, NY 12205 - ONSITE in-office Mon through Fri Job Description: These roles serve as Public Information Assistants related to the digital content of the Department's websites. They will be specifically responsible for posting approved digital content...