Senior Regulatory Affairs Consultant

Project Services   - Basel, Frankfurt, Kosice, Singapore, Boston

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Your profile / requirements

• 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. 

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