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Description

The Regulatory Specialist’s role is to organize and lead regulatory efforts to ensure optimal interactions with regulatory authorities and regulatory approval.

Responsibilities:

  • Prepare documents such as pre-submission requests and marketing clearance requests
  • Work independently to prepare document packages for regulatory submissions including 510(k)s, Design Dossiers, Technical Files, Device License Applications, Investigational Device Exemptions, and Pre-market Approval Applications
  • Track and coordinate regulatory submission activities to ensure timeliness and commitments are met
  • Coordinate responses to regulatory agencies and notified bodies as part of the submission and approval process
  • Review and approve Engineering Change Orders in accordance with regulatory requirements
  • Review and approve test protocols to support regulatory submissions
  • Review device labeling and advertising material for compliance with submissions
  • Assist in regulatory compliance activities, including but not limited to Notified Body Audits, FDA Inspections, and other regulatory agency inspections and audits
  • Maintain regulatory files
  • Perform internal audits of the Quality Management System
  • Provide on-going support to project teams for regulatory issues and questions
  • Find, interpret and apply regulations and guidance appropriately for situations

Qualifications

Requirements:

  • Bachelor’s degree
  • Knowledge and experience with ISO 13485, ISO 14971, 21 CFR 820, and IEC 62304
  • At least 5 years of experience in regulatory affairs in the medical device, biotech or pharmaceutical environment
  • Strong written and oral communication skills with technical, scientific, medical and business groups
  • Working knowledge of GMPs and GCPs required
  • Regulatory submission experience in US and EU, including but not limited to 510(k), PMA, DeNovo, and/or Technical Files

Preferred:

  • 7+ years medical device industry experience
  • Master’s Degree in Engineering, Quality, Regulatory, or related
  • Experience working at the FDA
  • Regulatory compliance experience in the medical device area preferred
  • Strong negotiation and communication skills
  • Strong organizational and time management skills

Contact Us for More Information

We're always looking for talented, motivated individuals to join our team - get in touch!

careers@deep.health

Contact Us About This Position

We're always looking for talented, motivated individuals to join our team - get in touch!

careers@deep.health