Associate Director, Global Regulatory Affairs
Our large medical device client is seeking a candidate with a strong global (e.g., EMEA, LAO, APAC) R.A. background to manage projects and Regulatory Affairs staff to ensure medical device design and registration activities are aligned with dynamic global regulations within the expanding regions. The individual will help with continuously improving and maintaining systems for managing Regulatory Affairs data and for ensuring active regulatory compliance.
? Provide leadership to maintain compliance with constantly changing domestic and international regulations as well as management of state and/or local Licenses.
? Provide leadership ensuring that compliant regulatory strategies are developed in alignment with business objectives and implemented efficiently within timelines.
? Ensure that domestic and international regulatory submissions (e.g., Q-Subs, 510(k)s, IDEs, Technical Files, Design Dossiers, License Applications, Establishment Registrations and Product Listings, CFGs, MDRs, Vigilance Reports, MDPRs, etc.) are prepared and submitted accurately, completely and in a timely manner to meet and maintain business objectives.
? Oversight of Adverse EventReporting process (e.g., MDR, Vigilance, MDPR, etc) to ensure that reports are prepared per procedure and guidelines and submitted within mandated time-lines.
? Lead the preparation and execution of Field Action activities.
? Help maintain an information network for monitoring domestic and international regulatory developments, followed by appropriate preventive communication and training within the Company.
? Contribute to and participate in the review of process/product changes, labeling, claims, complaints, etc., to determine the need for any regulatory activities and to ensure compliance to FDA and international requirements.
? Provide regulatory support for new/modifications to product design/ project teams.
? Support and participate in audits performed by internal and external representatives (e.g., FDA, Notified Body, etc.).
? Lead the implementation of regulatory initiative throughout the Company ? and its facilities, includes import-export support.
? Follow-up, track and assemble regulatory commitments to regulatory Agencies as required.
? Bachelor?s Degree
? Eight to ten years?experience in Regulatory Affairs.
? Exceptional written and verbal communication skills.
? Team player with excellent organizational skills.
? Detail-focused with ability to multitask effectively and work efficiently within a strict timeline-driven environment.
? Demonstrated success in the preparation and acceptance of both domestic and international medical device submissions for obtaining successful marketing authorizations.
? Extensive experience navigating global medical device regulations for multiple regions.
? Computer Skills, Microsoft windows (Excel, Word, Outlook) and Access.
? Experience managing projects using a High Performance Management System.
? Technical background and Advanced Degree
? Regulatory Affairs Certification (RAC).