Paragon 28s growth continues and were looking for more great employees! Now is your chance to join this public company dedicated to improving patients quality of life with the treatment of the most challenging foot and ankle conditions! We are currently looking to fill the position of Regulatory Affairs Specialist I with a starting range of $70,000 - $95,000/year, dependent upon experience, education, and skills. This position requires a full-time onsite presence.

The Regulatory Affairs Specialist I collaborates with the Regulatory Affairs, Engineering, and Quality teams to ensure compliance with all regulatory requirements for Paragon 28 products distributed in the United States, Canada, and other territories/regions as assigned. This position is responsible for regulatory strategies, submissions, and communication with government agencies (e.g. FDA, Health Canada), as well as regulatory assessments and reviews of quality management system documents.

Key Responsibilities

• Review and understand global regulatory requirements (FDA, TGA, EU MDD, EU MDR, Health Canada, etc.)
  • Maintain compliance to FDA UDI requirements
• Assemble and maintain regulatory files (510(k) submissions, STED, Technical Files, etc.)
  • Assist engineering in implementing verification and validation strategies
  • Work with regulators to release products into new or established markets
  • Review and establish predicates for FDA premarket notifications
  • Review competitive literature to develop regulatory strategies
• Support project teams in decisions that affect regulatory compliance
• Review marketing literature for regulatory compliance
• Registration and listing of devices
• Create and maintain product labeling
• Knowledge of GMPs
• Other duties as assigned

• 
  Associate degree (Engineering, Biology, or Regulatory Science) and 2-5 years related experience; or equivalent combination of education and experience.
• Knowledge of 21 CFR Part 820, EU MDD 93/42/EEC, EU MDR 2017/745, and ISO 13485
• Basic understanding of orthopedic devices; prefer previous medical device industry experience
• History of working collaboratively across functions
• Excellent attention to detail and proven organizational skills, able to prioritize and multi-task and see projects/assignments to completion
• Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems
• Proven leadership and negotiation skills, works well with all levels, able to successfully manage cross-departmental expectations
• Excellent written and verbal communication skills