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Regulatory Affairs Manager

Company: Genius Talent
Location: Stratford
Posted on: June 20, 2022

Job Description:

Genius Talent has partnered with a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. The team supports start-ups, mid-sized private companies and the largest corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implantables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical mobile apps, in vitro diagnostics and more. We are seeking an experienced Regulatory Affairs Manager to support U.S. and international regulatory activities as well as be an individual contributor on regulatory projects for Experien Group clients. The Regulatory Affairs Manager will participate in the planning, development and execution of regulatory submissions. The Regulatory Affairs Manager will coordinate activities of the Regulatory organization with responsibility for results in terms of costs, methods, and employees. This person is also responsible for ensuring all activities are in compliance with Quality System requirements. MAJOR DUTIES OF THE POSITION --- Develops and establishes strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients, to drive client corporate initiatives to completion. --- Assumes a leadership role for project management. Works independently to represent regulatory affairs on project teams bringing novel products and manufacturing processes from concept, through development, to market for clients. Ensures product registration requirements are understood by project teams in order to create technical reports during development that will support global registrations. --- Reviews and approves product labeling and marketing material, including websites and social media. Initiates new package inserts and other required product labeling. --- Manages/prepares elements of regulatory submissions (e.g., IDEs, 510(k)s, PMAs, HDEs, Technical Files, Design Dossiers, and international registrations). --- Manages preparation of pre-submission packages, Humanitarian Use Device designation requests and Non-Significant Risk proposals for regulatory and clinical activities. --- Prepares regulatory/clinical strategy packages for executive review, including performing predicate research and relevant literature review from peer reviewed journals. --- Reviews clients' design history file documentation, including verification/validation, biocompatibility, sterilization, transit and aging documentation, risk management documentation and device draft labeling. --- Prepares Clinical Evaluation Reports for executive review in accordance with current standards. --- Processes and reviews clients' complaint files (including submission of MDRs, Vigilance Reports and Mandatory Problem Reports). KNOWLEDGE AND SKILL REQUIREMENTS --- A technical degree is required, master's preferred. --- A minimum of 7-10 years of related work experience. --- Cardiovascular and Digital Health (SaMD) experience highly desired. --- Knowledge of FDA's Quality System Regulation (QSR) and the changing EU Medical Device Regulation (MDR) is required. --- High level of professionalism, including strong verbal and written skills, is mandatory. --- Strong leadership attributes are necessary. Candidate will lead cross-functional discussion and drive projects to completion. Mentors junior staff on regulations and company policies and procedures. --- Candidate should possess exceptional project management and technical writing skills.

Keywords: Genius Talent, Visalia , Regulatory Affairs Manager, Executive , Stratford, California

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