Senior Regulatory Affairs Specialist

Posted 25 January 2022
Salary Up to US$0.00 per annum
Location
Job type Permanent
ReferenceBBBH128237_1643136869
Contact NameMelody Lam

Job description

Senior Regulatory Affairs Specialist - Medical Device
Location: San Diego, CA (remote)


Our client primarily develops medical devices and procedures for minimally invasive spine surgery including software systems for surgical planning and monitoring, access instruments, and implantable hardware.


The Senior Regulatory Affairs Specialist will create and prepare document packages for regulatory submissions for new and existing products, ensuring compliance with local and regional registration requirements. Executes timely regulatory strategies to meet company goals and maximized efficiencies. Compiles all materials required for STED submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking and control systems. Keeps abreast of regulatory procedures and changes. Recommends strategies for earliest possible approvals of clinical trials applications.

  • Determines the appropriate regulatory strategy for new and existing products and documents all related activities to remain in compliance
  • Demonstrates global regulatory expertise in product submissions and evaluates changes with local regulations
  • Collaborates with various departments to review the required plans, procedures and regulatory decisions for new or existing products
  • Reviews regulatory requirements from other departments for new product designs or changes to existing designs
  • Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
  • Prepares and maintains regulatory pre-market submissions and other pre-market filings to assist in acquiring appropriate commercial distribution clearances
  • Supports product import by providing applicable regulatory documentation and certificates
  • Performs other duties as assigned


Background Qualifications:

  • Minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree
  • Understanding of regulatory requirements throughout the product lifecycle
  • Solid understanding of regulatory terminology, pre-market submission types, and requirements
  • Able to evaluate regulatory impact of proposed product and process changes
  • Capable multi-tasking skills with the ability to project plan and meet deadlines
  • Result driven with a sense of responsibility, urgency and ability to perform under pressure