West Pharmaceutical Services, Inc
Senior Regulatory Affairs Specialist
West Pharmaceutical Services, Inc, Exton, Pennsylvania, United States, 19341
Title: Senior Regulatory Affairs Specialist
This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week at our Exton PA. Who We Are:
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. Job Summary The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. Essential Duties and Responsibilities
Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner. Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release. Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. Provide leadership to cross functional teams for regulatory issues and questions. Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products. Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc. Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers. Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals 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 Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required Education
Bachelor’s degree or equivalent experience is required Master’s degree or PhD in science, math, engineering, or related discipline preferred Work Experience
Minimum 5 years of relevant experience 2+ years of medical device regulatory experience preferred Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745) History of successful international device registration, EU MDR technical documentation and/or US 510(K) authoring experience Advanced knowledge of ISO 13485 Advanced knowledge of product life cycle, product development process, design control and change control Experience interacting with government agencies Excellent oral communication, technical writing, and decision-making skills Preferred Knowledge, Skills and Abilities
Attention to detail with planning, time management and organizational skills Regulatory compliance competency including Quality Systems Experience with administration and safety systems preferred Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement. West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics.
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This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week at our Exton PA. Who We Are:
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. Job Summary The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. Essential Duties and Responsibilities
Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner. Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release. Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. Provide leadership to cross functional teams for regulatory issues and questions. Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products. Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc. Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers. Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals 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 Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required Education
Bachelor’s degree or equivalent experience is required Master’s degree or PhD in science, math, engineering, or related discipline preferred Work Experience
Minimum 5 years of relevant experience 2+ years of medical device regulatory experience preferred Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745) History of successful international device registration, EU MDR technical documentation and/or US 510(K) authoring experience Advanced knowledge of ISO 13485 Advanced knowledge of product life cycle, product development process, design control and change control Experience interacting with government agencies Excellent oral communication, technical writing, and decision-making skills Preferred Knowledge, Skills and Abilities
Attention to detail with planning, time management and organizational skills Regulatory compliance competency including Quality Systems Experience with administration and safety systems preferred Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement. West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics.
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