Senior Regulatory Affairs SpecialistPosted: November 16, 2009
Title: Senior Regulatory Affairs Specialist Location: Maryland-Baltimore Responsible and accountable for developing and executing sound strategies for complex submissions to FDA and other regulatory agencies. Represents the business in interactions with regulatory authorities and plays a prominent role in complex negotiations regarding (1) clinical and analytical study designs during the pre-submission phase and (2) acceptable claims, wording, performance data and other information at the pre-clearance/approval phase. Position is critical to the timely marketing of products. With minimal guidance from the functional leader, interprets statutes, regulations and guidances for business teams and product development teams, communicating how these impact development, manufacturing, and/or marketing. Works on complex problems where analysis requires in-depth evaluation of multiple factors. Exercises judgment within broadly defined practices and policies in deciding how to address or resolve issues. Is considered a regulatory expert within the organization. * Develops strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments and regulatory options to business teams and to product development/support teams. * Represents the business in interactions with regulatory authorities and plays a prominent role in complex negotiations regarding (1) clinical and analytical study designs during the pre-submission phase and (2) acceptable claims, wording, performance data and other information at the pre-clearance/approval phase. * Organizes and manages meetings with regulators, including development of agendas and training/preparation of company personnel attending these meetings. * Interprets statutes, regulations, policies and guidances for business teams and product development/support teams, communicating how these impact product development, manufacturing, and/or marketing. * Coordinates and prepares, or directs the preparation of, regulatory submissions, including 510(k) premarket notifications and documentation required for registration of products outside the U.S. Prepares Investigational Device Exemption (IDE) applications and Premarket Approval Applications (PMA). Exercises considerable latitude in determining how to most efficiently organize activities to complete these submissions. * Prepares or provides input into Technical Files for CE marking, and interfaces as needed with Notified Bodies regarding significant changes to products. * Remains current on regulatory issues/trends affecting business unit products, assessing and communicating their impact to RA colleagues, product development/support teams, and to others in the business. * Reviews and approves labels/labeling and promotional and advertising materials to ensure regulatory compliance. * Reviews analytical and clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance. * Participates on product recall committees, assisting in classifying the recall and in identifying actions that must be taken. * Represents business in external organizations such as AdvaMed, CLSI, and STMA to put forth BDs positions and advocate on BDs behalf. * May serve as a Core Team Member (CTM) with responsibility for directing the activities of Extended CTMs. * May mentor and provide guidance to less experienced RA professionals in terms of regulatory knowledge and skills in project management, effective team participation and communication. * May lead cross-functional or cross-business teams to address process improvements in the regulatory area or major regulatory changes. * Serves as a consultant to management on important matters pertaining to regulatory policies and strategies. * B.S. degree or higher in a technical discipline, including engineering, bioengineering, microbiology, molecular biology, biology, or chemistry. * RAPS Certification required. * Minimum seven years of directly related regulatory experience in the medical device and/orin vitrodiagnostic device area(s). * Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change. * Demonstrated success in preparing, filing and completing (including negotiations) regulatory submissions/dossiers (e.g., 510(k), IDE, PMA, Technical Files). * Demonstrated success in negotiating with regulatory agencies on (1) clinical and analytical study designs during the pre-submission phase and (2) acceptable claims, wording, performance data and other information at the pre-clearance/approval phase. * Experienced in arranging for, meeting with, and making presentations to regulators. * Ability to analyze complex issues and to formulate cogent approaches to resolving/addressing issues. * Ability to communicate and interact effectively (verbally and in writing) across multiple levels, disciplines, and regions. * Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. * Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. Minimal supervision required. * FDA regulations and policies applying to medical devices andin vitrodiagnostic devices including, but not limited to, requirements for 510(k)s, IDEs, PMAs, labeling and promotional materials, and Research Use Only devices. Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders. * EU regulations including, but not limited to, MDD 93/42/EEC and IVDMDD 98/79/EC. Must be able to interpret regulatory requirements, determine what is necessary for compliance, and effectively communicate this information to stakeholders. * Working knowledge of 21 CFR 820 - Quality System Regulation, ISO 9001:2000, Good Clinical Practice, and Good Laboratory Practice. * Working knowledge of standards applicable to business unit products.
Please refer to job code bdworldwide-REG0001P when responding to this ad.
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