Regulatory Specialist

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

Required:

• 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