Piper Companies is seeking a Regulatory Affairs Specialist to join an orthopedic medical device company headquarters in Audubon, Pennsylvania. The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for 510(k) submissions, as well as approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products.

Responsibilities of the Regulatory Affairs Specialist include:

• Partner with Product Development and management to prepare and review 510(k)submissions, as well as preparing final 510(k) submissions and obtaining required management approval
• Assist in the completion of IDE and PMA submissions for IDE clinical trials, help prepare PMA packages, including non-clinical manufacturing, and clinical sections, as well as obtain and review clinical study data, as needed for IDE and PMA reporting and routine maintenance of approved PMAs coordination and preparation
• Review Document Change Orders for Regulatory Compliance, including drawings and labeling changes
• Determine Regulatory Pathway for new/changed products under departmental guidelines and train new staff on relevant Regulatory process
• Review and approve Note-to-File documentation for minor changes to 510(k) cleared products or systems and understand company’s products
• Develop relevant Regulatory SOPs when necessary

QUALIFICATIONS FOR THE REGULATORY AFFAIRS SPECIALIST INCLUDE:

• Bachelor’s degree in health or science-related field, Engineering degree is a plus
• Minimum of 2-5 years’ experience in Regulatory Affairs in the medical device industry, preferably within orthopedic medical devices
• Demonstrated knowledge of US regulatory submissions; Pre-Sub, and 510(k); working knowledge of IDE and PMA submissions a plus
• Experience assessing regulatory impact of product/process changes, experience reviewing labeling, promotional literature, etc.
• Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
• Excellent communication, listening, time management skills, as well as demonstrating ability to work on multiple projects at once

• Partner with Product Development and management to prepare and review 510(k)submissions, as well as preparing final 510(k) submissions and obtaining required management approval
• Assist in the completion of IDE and PMA submissions for IDE clinical trials, help prepare PMA packages, including non-clinical manufacturing, and clinical sections, as well as obtain and review clinical study data, as needed for IDE and PMA reporting and routine maintenance of approved PMAs coordination and preparation
• Review Document Change Orders for Regulatory Compliance, including drawings and labeling changes
• Determine Regulatory Pathway for new/changed products under departmental guidelines and train new staff on relevant Regulatory process
• Review and approve Note-to-File documentation for minor changes to 510(k) cleared products or systems and understand company’s products
• Develop relevant Regulatory SOPs when necessar