Senior Regulatory Affairs Consultant

Minimum Qualifications

• Bachelor\’s or Master\’s degree in Life Sciences, Regulatory Affairs, Pharmacy, or a related field.
• Minimum of five years\‘ experience in Regulatory Affairs within the medical device and pharmaceutical industries, with a strong focus on FDA processes.
• In-depth knowledge of FDA regulations, guidelines, and submission processes for both medical devices and pharmaceutical products.
• Demonstrated success in managing submissions and gaining device and drug approvals.
• Excellent written and verbal communication skills.
• Leadership skills and the ability to form effective teams for project delivery.
• Proficiency in project management and ability to handle multiple projects simultaneously.
• Deep understanding of Good Manufacturing Practices (GMP), Quality System Regulations (QSR), and Good Clinical Practices (GCP).
• Willingness to travel.
• Professional certification in Regulatory Affairs (RAC) is preferred.
• Experience with Class II and Class III medical devices and ATMPs preferred.
• Experience with SaMD, including AI incorporation is preferred.
• Previous consulting experience is preferred.

Tasks and Responsibilities

• Develop and implement regulatory affairs services and related capabilities according to current and future market needs and trends.
• Support business development on regulatory affairs related services.
• Consult with clients to develop regulatory strategies, identifying the most efficient and compliant pathways for bringing their medical devices and pharmaceutical products to market.
• Consult with clients on the clinical data necessary to support device and drug approval.
• Consult with clients in implementation of additional components beyond the standard ISO 13485, that incorporates Artificial Intelligence (AI), i.e. focus on data management, AI-specific risk management, ethical considerations.
• Prepare, review, and submit high-quality regulatory submissions for global registration, including 510(k) Notices, PMA applications, De Novo requests, IND applications, and NDA submissions.
• Serve as the main liaison between clients and regulatory authorities, facilitating effective communication and swift resolution of issues.
• Support clients in the post-market surveillance and reporting process, including guidance on MDRs, recalls, inspections, and adverse event reporting for pharmaceutical products.
• Keep abreast of changes regulatory guidelines, standards, and policies, interpreting their implications for client projects.
• Provide training to clients\‘ internal teams on FDA regulations, guidelines, and processes.

#J-18808-Ljbffr