Piper Companies is seeking a full-time Regulatory Specialist for an established medical device company. This is a full time position that is 100% onsite in Audubon, PA. The Regulatory Specialist is responsible for preparing and submitting regulatory documentation to the FDA for Class II and III medical devices, ensuring compliance with relevant regulations and supporting product development teams throughout the submission process.

QUALIFICATIONS FOR THE REGULATORY SPECIALIST:

• Bachelor’s degree in a health or science-related field; Engineering degree preferred.
• 2–5 years of experience in Regulatory Affairs within the medical device industry, ideally orthopedic devices.
• Strong knowledge of FDA regulatory submissions including 510(k), Pre-Sub, IDE, and PMA.
• Experience with clinical data review and regulatory impact assessments of product changes.
• Familiarity with labeling and promotional material review for regulatory compliance.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Teams).
• Strong organizational and time management skills; ability to manage multiple priorities independently and collaboratively.

• Collaborate with cross-functional teams to prepare and submit 510(k), IDE, and PMA documentation to the FDA.
• Review and approve regulatory documentation including labeling, drawings, and change orders for compliance.
• Maintain and update approved PMAs, including supplements and annual reports.
• Assess regulatory pathways for new or modified products and approve supporting documentation.
• Train new staff on regulatory processes and contribute to the development of SOPs.