Regulatory Affairs Specialist

About This Role

This specialist role provides leadership in regulatory affairs, focusing on medical device regulations, documentation, and expert consultancy for IZiel Healthcare clients. The role involves working with clients globally to secure product approvals in Europe and the USA, requiring continuous training in country-specific regulations and representing IZiel at various forums. A key responsibility will be ensuring clients' high-end products comply with the new CE Medical Device Regulation (MDR).

Responsibilities

• Have extensive knowledge of regulatory pathways for medical device approvals in various countries, with a primary focus on US and European regulatory pathways
• Research data and develop a regulatory strategy for approval of products for medical device manufacturers
• Have knowledge of USFDA establishment registration and device listing
• Write 510(k) and PMA applications with relevant information and input from the engineering teams
• Prepare design and development documentation to align with the regulatory strategy
• Compile technical files and design dossiers as per USFDA and CE guidelines
• Perform documentation as per FDA and CE-MDR regulations and ISO standards
• Perform audit compliances, analyzing gaps and shortcomings as per FDA and ISO regulations
• File annual reports and manage regulatory changes per the respective FDA and CE mark guidelines
• Understand cGMP regulations per 21 CFR and ISO 13485
• Understand Risk Management per ISO19471

Requirements

• Bachelor's in Pharma with 4+ years of experience OR Master's in Pharma with 2+ years of experience
• Technical writing, English communication and teamwork
• Detail oriented, with the ability to read various standards and guidelines and define implementation details

About the Company

Engineers are key to success in this organization, which values their skills in furthering the cause of helping lives. This opportunity is in the IZiel Healthcare division. IZiel group provides engineering and regulatory services, engineering design and analysis, and resource placement services, working with global medical device manufacturers, automotive, engineering, and oil and gas clients. Thorough leadership, robust work planning methodology, and exceptional customer service are the key enablers of its success.