You are viewing a preview of this job. Log in or register to view more details about this job.

Regulatory Affairs Associate

Roles and Responsibilities:
  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Core job responsibilities for this function may include: 
  • Provide regulatory input to product lifecycle planning.
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
  • Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context to assess regulatory implications for approval.
  • Determine and communicate submission and approval requirements.
  • Participate in risk-benefit analysis for regulatory compliance Premarket
  • Monitor applications under regulatory review.
  • Evaluate proposed changes for regulatory filing strategies.
  • Assist in preparation and review of regulatory submission to authorities' post-market
  • May help maintain annual licenses, registrations, and listings.
  • Assist compliance with product post-marketing approval requirements.
  • Assess external communications relative to regulations.
  • Assist with label development and review for compliance before release.
  • Submit and review change controls to determine the level of change and consequent submission requirements.
  • Maintain submission files (e.g., technical files)
  • Compendial / standards 
  • Import / export 
  • Country specific regulatory support.
Education and Experience:
  • Regulatory work experience from medical device industry (e.g., IVD, diagnostics, or similar). Will also consider experience from pharmaceutical industry.
  • Experience or strong working knowledge of ISO 13485, 510k, or similar.
  • Required Qualifications 
  • Bachelor's Degree (or equivalent); Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.  
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)   
  • 3 years' experience in a regulated industry (e.g., medical products, nutritional). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
  • Regulatory history, guidelines, policies, standards, practices, requirements, and precedents 
  • Regulatory agency structure, processes, and key personnel 
  • Principles and requirements of applicable product laws 
  • Submission/registration types and requirements 
  • GxPs (GCPs, GLPs, GMPs) 
  • Principles and requirements of labeling 
  • Domestic and international regulatory guidelines, policies, and regulations 
  • Communicate effectively verbally and in writing 
  • Communicate with diverse audiences and personnel 
  • Write and edit technical documents 
  • Work with cross-functional teams 
  • Work with people from various disciplines and cultures 
  • Write and edit technical documents
  • Pay strong attention to detail 
  • Manage projects 
  • Create project plans and timelines 
  • Think analytically and critically 
  • Organize and track complex information 
  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions 
  • Apply business and regulatory ethical standards