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Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist
Remote or Onsite in San Diego
Posted on 10/19/2022
INACTIVE
Locations
Remote
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Marketing
Product Design
Sales
PowerPoint/Keynote/Slides
Requirements
  • For Senior Regulatory Affairs Specialist: Bachelor's degree (BS/BA) in biological/life science, related field or equivalent required (or equivalent combination education and/or work experience) with a minimum of 5 - 8 years' experience in a pharmaceutical, medical device or IVD manufacturing environment
  • For Regulatory Affairs Specialist: Bachelor's degree (BS/BA) in any biological science (or equivalent combination education and/or work experience). 1 to 3 years' experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry manufacturing environment is preferred
  • RAC Certification preferred
  • Direct interactions with FDA and other regulatory agencies preferred
  • Experience in the preparation and submission of regulatory documentation including 510(k) submissions and/or international registrations is required
  • Strong knowledge of quality systems in a manufacturing environment; working knowledge of current and evolving state, federal and international regulations and procedures relevant to the approval of medical devices (current FDA, QSR, ISO, CMDR, IVDD, IVDR and other worldwide regulatory regulations as appropriate)
  • Ability to work cohesively with multi-disciplinary scientific working groups
  • Excellent written and verbal interpersonal skills to influence many diverse internal/external customers
  • Ability to support clinical and safety departments in order to meet corporate objectives
  • Ability to work on multiple projects simultaneously
  • Possess a high degree of accuracy and attention to detail
  • Work on assignments of moderate scope where independent action and a high degree of initiative are required in resolving problems and developing recommendations
  • Ability to handle inter/interdepartmental issues in a cooperative and diplomatic manner
  • Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
Responsibilities
  • Develops regulatory strategies for products in development to achieve market clearance in the US and internationally
  • Provides regulatory guidance for verification and validation study protocols and reports for regulatory submissions
  • Prepares and publishes regulatory documentation for domestic and international product submission and registration
  • Secures regulatory documentation including device licenses, device listings, permits, import/export certificates and annual global registrations
  • Supports corporate regulatory compliance activities including Comprehensive Compliance Program (CCP)
  • Provides regulatory guidance, review and approve Marketing/Sales literature and labeling
  • Supports external regulatory inspections and/or audits (including FDA, ISO, IVDD, IVDR CMDR, MDSAP)
  • Participates in internal auditing and training systems to ensure compliance with quality system
  • Interprets FDA/IVD/medical device regulations and guidelines and interact with development project teams to provide guidance and complete regulatory deliverables during the product development process
  • Awareness of device defects that may occur including product design, verification and validation, manufacturing and testing activities
  • Researches regulations and competitor products, creates summaries for departmental use and keep informed of global regulatory information
  • Supports clinical trials through coordination of activities, providing input into protocols and reviewing/auditing data
  • Maintains notary public certification and execute notarial services
  • Other duties or projects as assigned
Quidel

501-1,000 employees

Diagnostic healthcare manufacturer
Company Overview
Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of families, communities, and the world. The company is delivering a continuum of diagnostic solutions from advanced lateral-flow, direct fluorescent antibodies, and molecular diagnostic tests that improve the quality of healthcare.
Benefits
  • Medical, dental, & vision
  • 401k
  • Income replacement
  • Employee stock purchase plan
  • Vacation & Holidays
  • Great work environment
Company Core Values
  • Customer Driven
  • Focused on Execution
  • New Product Oriented
  • Determined
  • Optimistic
  • Team Players