Regulatory Affairs Specialist II

Katalyst CRO; Exton (Chester County); On-site; USD 85,000 - 120,000; Full time

Job summary

A leading company in medical technology is seeking a Regulatory Affairs Specialist to manage regulatory strategies and submissions for software and hardware in the medical device space. The ideal candidate will possess strong insight into FDA regulations for SaMD and demonstrate expertise in compliance, strategy development, and communication across cross-functional teams.

Qualifications

• Minimum 3 years' experience in regulatory affairs with SaMD.
• Proven experience with 510(k) and De Novo submissions.
• RAC certification or equivalent is preferred.

Responsibilities

• Develop regulatory strategies and prepare submissions.
• Serve as the global regulatory liaison for product teams.
• Maintain knowledge of regulations related to SaMD and AI.

Skills

Attention to detail

Organizational skills

Collaboration

Communication skills

Education

Bachelor's degree in Engineering, Biology, or Regulatory Science

Tools

Excel

Word

PowerPoint

Outlook

Customer database management systems

Job description

Responsibilities

• Responsibilities include developing regulatory strategies, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses and interacting with regulatory agencies.
• Serve as the global regulatory liaison and primary point of contact for product and project teams for Paragon 28 software applications and surgical system hardware.
• Maintain expert knowledge of appropriate regulations, legislation, best practices, and guidelines related to Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML).
• Provide regulatory guidance to product teams, develop regulatory strategies, and review and approve product design control documentation.
• Author and lead regulatory documentation and submissions, including (but not limited to) U.S.
• FDA 510(k) premarket notifications, De Novo applications, internal Letters to File, and pre-submissions, with minimal supervision.
• Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals.
• Provide risk-based guidance and regulatory input to projects and issues, ensuring cross-functional alignment and resolution.
• Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts.
• Perform timely reviews of collateral Marketing material for responsible product lines.
• Build relationships and interface with cross-functional teams (Engineering, Manufacturing, Marketing, etc.).
• Assess impact of changes to applicable laws and regulations and identify impact to the business and in collaboration with other stakeholders, develop strategies to address such changes.
• Review and understand global regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.).
  
  

Requirements:

• Bachelor's degree (Engineering, Biology, or Regulatory Science) and a minimum of 3+ year(s) related experience or equivalent combination of education and experience Proven experience with software as a medical device (SaMD) and mobile health app regulations.
• In-depth knowledge of FDA guidance on digital health, cybersecurity, and mobile medical apps.
• Track record of 510(k)/De Novo submissions for connected orthopedic or wearable devices.
• Experience with EU MDR requirements for software and app-based devices (Annex I & XIII).
• Regulatory strategy development for Bluetooth/Wi-Fi enabled orthopedic technologies.
• Effective collaboration with software, clinical, and human factors teams.
• Post-market compliance expertise, including UDI, vigilance, and software change reporting.
• Strong understanding of cybersecurity requirements and guidance (e.g., FDA, IMDRF).
• RAC certification or equivalent, with ongoing education in digital health regulations.
• Knowledge of US and/or international regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.).
• Direct experience with regulatory submissions for Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML) product.
• Understanding of orthopaedic devices.
• Excellent attention to detail and proven organizational skills, able to prioritize and multi-task and see projects/assignments to completion.
• Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems.
• Excellent written and verbal communication skills.
• Less than 15% of overnight travel; potential for either domestic or international travel.