510k Medical Device Consultant

Apotech is a Life Science Management Consultancy, delivering outsourced services in Quality and Regulatory Affairs. After three successful years, we are in a growing phase with big ambitions! Fundamental to the business is to continue to create an organisation where employees are excited to come to work, are proud of what we do & who we are and push the boundaries of social responsibilities. We are now seeking a 510k Medical Device consultant to join our amazing team. 

Job Title: 510k Medical Device Consultant 

Location: Flexible/Remote or willing to travel onsite within the EU 

Position Overview: We are seeking a proficient and experienced freelance 510(k) Medical Device Consultant to join our team. The ideal candidate will have a thorough understanding of FDA regulations, quality systems, and submission requirements specific to the 510(k) premarket notification process for medical devices. As a freelance consultant, you will provide strategic guidance, regulatory expertise, and support to clients seeking FDA clearance for their medical devices through the 510(k) pathway.

Responsibilities:

• Collaborate with clients to assess the regulatory pathway for their medical devices and determine the appropriate strategy for obtaining FDA clearance through the 510(k) premarket notification process.
• Review and evaluate clients’ product development plans, design documentation, risk management files, and testing protocols to ensure compliance with FDA regulations and submission requirements.
• Assist clients in preparing and assembling 510(k) submissions, including the preparation of cover letters, administrative sections, device descriptions, indications for use, substantial equivalence analyses, and summary documents.
• Conduct regulatory assessments and gap analyses of clients’ quality systems, design control processes, and documentation to identify areas of non-compliance and opportunities for improvement.
• Provide guidance on the interpretation and application of FDA guidance documents, consensus standards, and industry best practices related to the 510(k)-submission process.
• Coordinate with cross-functional teams, including engineering, quality assurance, clinical affairs, and regulatory affairs, to gather the necessary information and documentation for 510(k) submissions.
• Review and respond to FDA requests for additional information (AI letters), deficiency letters, and inquiries related to 510(k) submissions in a timely and thorough manner.

Requirements:

• Bachelor’s degree in engineering, life sciences, or a related field. 
• Advanced degree (e.g., master’s or Ph.D.) preferred.
• Extensive experience in regulatory affairs, quality assurance, or compliance roles within the medical device industry, with a minimum of 5 years working directly with FDA regulations and submissions.
• In-depth knowledge of FDA regulations governing medical devices, including the 510(k) premarket notification process (21 CFR Part 807 Subpart E) and related guidance documents.
• Proven track record of successfully preparing and submitting 510(k) notifications for medical devices, including Class I, II, and III devices, across various product categories.