Regulatory Specialist
On-siteAudubon, Pennsylvania, United States
Audubon, Pennsylvania, United StatesOn-siteFull TimeHealthcare TechLarge
Full TimeLargeHealthcare Tech
Job Summary
Draft and submit 510(k), IDE, and PMA submissions to the FDA, preparing final documents and responding to agency inquiries. Partner with Product Development to review regulatory pathways, assess product changes, and manage document change orders. Obtain and review clinical study data for reporting, while preparing PMA packages including non-clinical, manufacturing, and clinical sections. Maintain approved PMAs through supplements and annual reports, and develop relevant Standard Operating Procedures. Train new staff on regulatory processes and ensure compliance with FDA 21 CFR regulations and company codes of conduct.
Required Qualifications
- Bachelor's degree in health or science-related field, or equivalent
- Engineering degree is a plus
- Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry
- Experience in medical device development and registration of products
- Demonstrated knowledge of US regulatory submissions; Pre-Sub, and 510(k)
- Working knowledge of IDE and PMA submissions
- Experience assessing regulatory impact of product/process changes
- Experience reviewing labeling, promotional literature, etc.
- Excellent communication and listening skills
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
- Strong time management skills
- Demonstrated ability to work on multiple projects, priorities simultaneously
- Able to work independently as well as within a team
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific vision abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
Desired Qualifications
- Engineering degree is a plus
- Experience in medical device development and registration of products
- 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.
- Excellent communication and listening skills
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
- Strong time management skills
- Demonstrated ability to work on multiple projects, priorities simultaneously
- Able to work independently as well as within a team
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