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West Pharmaceutical Services, Inc. Sr Specialist - Combination Product Regulatory Affairs in Exton, Pennsylvania

Reference #: 627241301Sr Specialist - Combination Product Regulatory AffairsExtonPennsylvaniaWorking at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate - which all help contribute to a Healthier World.At West, we are by the side of patients. The work we do impacts patients' lives each and every day - our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $1.84B in 2019. We serve by the side of our community. Giving back is in our DNA-our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.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 alt