Piper Companies
Piper Companies
is seeking a
Regulatory Affairs Specialist
to join an orthopedic medical device company in
Audobon, 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:
Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, preferably within orthopedic medical device Bachelor's degree in health or science-related field, Engineering degree is a plus 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 Compensation for the Regulatory Affairs Specialist include:
Salary Range: $80,000-90,000 Comprehensive Benefits: Medical, Dental, Vision, 401K, Sick Leave if required by law Full-time on-site in Audobon, PA
This job opens for applicants on 9/26/2025. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: Regulatory Affairs Specialist, medical device regulatory, 510(k) submissions, IDE submissions, PMA submissions, FDA compliance, Class II devices, Class III devices, orthopedic medical devices, regulatory documentation, regulatory strategy, Document Change Orders, Note-to-File, clinical trial support, regulatory SOPs, labeling review, promotional material review, regulatory impact assessment, Microsoft Office, cross-functional collaboration, time management, multitasking, Audubon PA, on-site role, full-time position, regulatory submissions expert , PMA, IDE, FDA
#LI-KG2 #LI-ONSITE
is seeking a
Regulatory Affairs Specialist
to join an orthopedic medical device company in
Audobon, 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:
Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, preferably within orthopedic medical device Bachelor's degree in health or science-related field, Engineering degree is a plus 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 Compensation for the Regulatory Affairs Specialist include:
Salary Range: $80,000-90,000 Comprehensive Benefits: Medical, Dental, Vision, 401K, Sick Leave if required by law Full-time on-site in Audobon, PA
This job opens for applicants on 9/26/2025. Applications for this job will be accepted for at least 30 days from the posting date.
Keywords: Regulatory Affairs Specialist, medical device regulatory, 510(k) submissions, IDE submissions, PMA submissions, FDA compliance, Class II devices, Class III devices, orthopedic medical devices, regulatory documentation, regulatory strategy, Document Change Orders, Note-to-File, clinical trial support, regulatory SOPs, labeling review, promotional material review, regulatory impact assessment, Microsoft Office, cross-functional collaboration, time management, multitasking, Audubon PA, on-site role, full-time position, regulatory submissions expert , PMA, IDE, FDA
#LI-KG2 #LI-ONSITE