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Summary
About the Role
About You
- 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.
- Excellent written and verbal communication skills.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Teams).
- Experience with clinical data review and regulatory impact assessments of product changes.
- Familiarity with labeling and promotional material review for regulatory compliance.
- Strong organizational and time management skills; ability to manage multiple priorities independently and collaboratively.
Benefits
- Comprehensive benefits package including Medical, Dental, Vision, 401(k), PTO, vacation, and sick leave.
- Competitive salary range of $80k–$90k depending on experience.
Piper Companies is a professional services and consulting partner that operates three distinct divisional business units specializing in Health Sciences, Enterprise Information Technology and Cyber & Cloud Security. Piper Health Sciences services the Life Sciences, Clinical Research, and Applied Health communities. Focused on delivering results by teaming with our customers to build, integrate, and support mission-critical initiatives. Piper regularly deploys top technical consultants and turnkey project solutions within highly regulated GxP environments, specifically within the Pharmaceutical, Biotechnology, Medical Device, and Consumer Goods industries. Piper Enterprise Information Technology services clientele including, but not limited to, Healthcare, Financial Services, Telecommunications, Technology Enablement, Entertainment & Gaming, Energy, Utilities, Transportation, Retail, and Insurance. C2 Cyber & Cloud Security brings unparalleled expertise to the table, shaped by the founding and scaling of Crypsis, a leading Digital Forensics and Incident Response (DFIR) company. Recognized by the world's largest cyber firms, we understand the intricacies of protecting critical infrastructure, securing networks, navigating cyber threats, managing cloud integrations, and identifying top-tier talent. Piper Health Sciences • Technical Operations and Manufacturing Sciences • Quality and Regulatory Compliance • Project Management • Commissioning, Qualification and Validation • Clinical Research Operations and Development • Applied Health Piper Enterprise Information Technology • IT Infrastructure & Cloud • Software Development • Business Intelligence & Data Analytics • Cyber and Information Security • Business Analysis and Project Management C2 Cyber & Cloud Security • Digital Forensics & Incident Response • Network Security • Security Operation • Security Architecting • Cloud Security