Regulatory Affairs Analyst

 

Responsibilities

  • Strong working knowledge of FDA regulations, guidance documents, 93/42/ECC (MDD), EU 2017/745 (EU MDR), ISO14971, ISO13485, MDSAP, and other global regulatory requirements and standards
  • Compiles all materials required in submissions, license renewal and annual registrations to FDA, Health Canada, China CFDA, and others
  • Helps drive applicable requirements of IEC 60601-1 and related medical device safety standards into design requirements
  • Provides technical support, regulatory guidance, and oversight for Safety (UL) and EMC testing including EMC and Safety test plans, working with test lab/test sites, review and approve test reports
  • Participates in post-market surveillance, GMP compliance, 3rd party audits, inspections, reviews and approves advertising and promotions materials
  • Recommends changes for labeling, manufacturing, marketing, and usability protocols for medical device regulatory compliance
  • Participates as team member to plan, develop, and implement regulatory strategy throughout the medical device product lifecycle
  • Adverse event determination and reporting to FDA, EU, and other countries
  • Helps determine and facilitate Field Actions and Recalls
  • Compiles Technical Files for Europe

 

Requirements

  • Bachelor’s Degree and 2 plus years of medical device regulatory compliance experience.

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