Regulatory Affairs Associate in Dover, NJ at Apex Life Sciences

Date Posted: 6/2/2018

Job Snapshot

Job Description


Regulatory Affairs Associate:

This position is responsible for the execution of activities that ensure the company’s regulatory compliance to the FDA and other Regulatory agencies worldwide and the maintenance of the quality management system to promote continuous improvement.

Description:

  • Create, review and ascertain regulatory impact of controlled documents, labeling and product inserts
  • Manage customer complaint investigation and corrective action implementation and effectiveness
  • Perform adverse event reporting (MDRs, FSCA)
  • Backup for Quality Assurance Batch Record Review
  • Develop and support quality plans for continuous improvement
  • Conduct internal audits of the Quality Management System
  • Coordinate and participate in third party audits of the Quality Management System (FDA, Notified Body, ANVISA) 
  • Regulatory assessment of manufacturing and design changes
  • Represent Regulatory Affairs in Risk Management
  • Trend Analysis/Report on Quality System performance to Management
  • Prepare and submit Regulatory filings including 510(k) Premarket notifications, design dossiers, technical files and global license applications.
  • Prepare and submit new applications and renewal for US and worldwide facility registrations
  • Determine the impact of changing regulatory requirements on our products and business and implement appropriate changes as require

Requirements:

  • BS in Biology, Immunology, Microbiology, Biochemistry, Regulatory or related discipline
  • Experience in medical device regulatory affairs 
  • Knowledge of regulatory requirements for medical devices such as 21 CFR, 98/79/EC, CMDR, ISO 13485, etc…
  • Prior experience in submission of 510(k) premarket notification
  • Time management
  • Ability to multi-task and prioritize
  • Excellent written and oral communication skills
  • Highly organized 
  • Proficient in MS Office and/or equivalent Google apps