Medical Device, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
In this role, you will be responsible for 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.
Essential Duties and Responsibilities:
•Complete regulatory assignments with guidance in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of submissions to Health Authorities [MAFs, 510(k)’s, Technical File], customer requests, etc. in compliance with regulations, guidelines and procedures.
•Support project development teams and communicate regulatory progress, decisions, strategies, etc.
•Support DVT strategy and related documents review.
•Support pre-clinical studies and international clinical studies.
•Review assigned technical project documentation, certifications, correspondences, and external communications, as needed.
•Provide assistance with customer regulatory requests, including regulatory letters, compliance questionnaires).
•Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals.
•Maintain 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 and seek better alternatives and drive change.
•Adhere to all applicable government and West regulations, practices and procedures to maintain compliance.
•Clearly and effectively communicate team/project progress/status, decisions, timelines, etc.
•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.
Education: Bachelor’s degree required with an emphasis in Science or related disciplines
Experience: 3-5 years of medical device / pharmaceutical experience specific related with medical device constituent of combination product, design control activities
Preferred Knowledge, Skills and Abilities:
•Knowledge of medical device regulatory affairs and design control process and management of regulatory support systems is a plus.
•Experience in regulatory medical device development and registration of class I and class II medical devices.
•Demonstrated ability to manage multiple tasks/projects/priorities simultaneously is required.
•Excellent interpersonal, communication and listening skills.
5% - 10% (Projects, Meetings, Training), with higher levels possible due to customer critical or business needs
Physical & Mental Requirements:
Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.
Internal Number: 11796
About West Pharmaceutical Services
West 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.