West Pharmaceutical Services, Inc. Senior Specialist, Regulatory Affairs-Medical Device (PA, AZ, remote options) in Exton, Pennsylvania
Reference #: 599878801Senior Specialist, Regulatory Affairs-Medical Device (PA, AZ, remote options)ExtonPennsylvaniaWest Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2018 sales of $1.7 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.Location: This position can be based out of Exton, PA, Sottsdale, AZ or remote.POSITION SUMMARY: This role is responsible for in the coordination, authoring, submitting regulatory filings to regulatory agencies to obtain registrations / clearance for medical devices. This position includes supporting internal and external customer regulatory requests and maintain knowledge of current US and international regulations/guidelines/policies applicable to West's products and services.PRIMARY DUTIES AND RESPONSIBILITIES:Complete moderately complex regulatory assignments independently in support of RandD and commercial programs with a focus on authoring, maintenance and tracking of dossiers for submission to regulatory agencies [MAFs, 510(k)'s, technical files] in compliance with regulations, guidelines and procedures.Communicate directly with Regulatory agencies in response to request for information, regulatory inquiries or in support of customer regulatory filings.Reviews product labeling, Instructions for Use (IFUs), Patient Leaflets, Sales/Marketing Literature, Web-site information and Booth Graphics for Class I / Class II medical devices to ensure adherence to applicable regulations and standards.Guide research initiatives relating to medical device and combination product development.Reviews information to relating to medical device complaints.Work with RA team to build Regulatory strategies for combination product development platform.Participate on project development teams and provide regulatory guidance and communicate regulatory progress, decisions, strategies, to cross functional teams.Review technical and design specifications, project documentation, regulatory plans, etc. providing guidance and direction where applicable.Provide customers with West product related information and data as required for regulatory submissions to European and Rest of World agencies.Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.Train, mentor and/or guide the activities of direct reports, RA staff members and peers to define and achieve personal, departmental and corporate objectives, as applicable.Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management.Maintain working knowledge of US and European pharmaceutical and medical device legislation as related to West's products and business.Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goalsMaintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change.Adhere to all applicable government and West regulations, practices and procedures to maintain compliance.Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, eCTD and others as required.