FDA – 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 FDA Consultant to join our amazing team. 

Job Title: FDA – Medical Device Consultant 

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

Position Overview: We are seeking a proficient and experienced freelance FDA Medical Device Consultant to collaborate with our team. The ideal candidate will possess comprehensive knowledge of FDA regulations, quality systems, and compliance standards specific to the medical device industry. As a freelance consultant, you will provide strategic guidance, regulatory expertise, and support to clients in navigating the complex FDA regulatory landscape and achieving compliance with applicable requirements.

Responsibilities:

• Advise clients on FDA regulations, standards, and guidance documents relevant to the development, manufacturing, and marketing of medical devices, including but not limited to 21 CFR Parts 803, 806, 807, 812, 820, and relevant guidance documents.
• Assist clients in preparing and submitting regulatory filings, including 510(k) premarket notifications, premarket approval applications (PMAs), investigational device exemptions (IDEs), de novo submissions, and other regulatory submissions, ensuring completeness, accuracy, and compliance with FDA requirements.
• Conduct regulatory assessments and gap analyses of clients’ quality systems, design control processes, risk management practices, and documentation to identify areas of non-compliance and opportunities for improvement.
• Develop and implement regulatory strategies, action plans, and remediation plans to address identified compliance gaps, mitigate risks, and achieve regulatory approval or clearance for medical devices.
• Provide guidance on the interpretation and application of FDA guidance documents, consensus standards, and international regulations (e.g., ISO 13485, ISO 14971) to ensure alignment with FDA requirements and industry best practices.
• Support clients in preparing for and managing FDA inspections, audits, and post-market surveillance activities, including responding to FDA inquiries, observations, and warning letters.
• Conduct training sessions and workshops for client personnel on FDA regulations, compliance requirements, and best practices for maintaining regulatory compliance.
• Represent clients in communications and interactions with FDA officials, regulatory agencies, notified bodies, and other stakeholders to address regulatory inquiries, submissions, and compliance issues.

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 Quality System Regulation (21 CFR Part 820), premarket requirements (21 CFR Part 807), and post-market surveillance requirements (21 CFR Part 803).
• Proven track record of successfully guiding medical device companies through FDA regulatory processes, including premarket submissions, regulatory approvals, and post-market compliance activities.