Regulatory Affairs Specialist

Piper Companies is seeking a Regulatory Affairs Specialist for an established medical device company. This role full-time/direct hire and is 100% onsite in Audubon, PA.

Responsibilities:

• 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.
• 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.

Qualifications:

• 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.

Compensation:

• Salary: $80,000-$90,000 ***depending on experience***
• Comprehensive Benefits: Medical, Dental, Vision, 401(k), PTO, vacation, and sick leave in accordance with applicable laws

This job opens for applications on 9/5/25. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

510(k), PMA, De Novo, IDE, FDA, MDR, IVDR, CE marking, EU MDR, regulatory submissions, regulatory strategy, medical devices, risk classification, technical file, design dossier, UDI, labeling compliance, regulatory compliance, quality systems, ISO 13485, ISO 14971, GHTF, regulatory documentation, health authority interactions, regulatory intelligence, regulatory audits, post-market surveillance, vigilance reporting, device registration, global regulatory affairs, regulatory pathways, regulatory operations, clinical evaluation reports (CER), biocompatibility, regulatory risk assessment, regulatory filings, SOPs, QMS, compliance audits

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