Senior Specialist, Regulatory Affairs

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week No relocation is provided for this opportunityWho 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. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Job SummaryThe 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. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.Essential Duties and ResponsibilitiesDevelop 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 goalsAdhere to all applicable government and West regulations, practices, and procedures to maintain complianceMaintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as requiredOther duties as assignedEducationBachelor’s degree or equivalent experience is required orMaster's degree or PhD in science, math, engineering, or related discipline preferredWork ExperienceMinimum 5 years of relevant experience2+ years of medical device regulatory experience preferredExperience 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 experienceAdvanced knowledge of ISO 13485Advanced knowledge of product life cycle, product development process, design control and change controlExperience interacting with government agenciesExcellent oral communication, technical writing, and decision-making skillsPreferred Knowledge, Skills and AbilitiesAttention to detail with planning, time management and organizational skillsRegulatory compliance competency including Quality SystemsExperience with administration and safety systems preferredAbility to triage and manage work priorities and to follow established processes while identifying areas for process improvementAdditional RequirementsAbility to comprehend principles of math, science, engineering, and medical device use.Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.Ability to review, collate, describe, and summarize scientific and technical data.Ability to organize complex information and combine pieces of information to form general rules or conclusions.Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.Ability to build strong relationships both internally and externally.Ability to work in a fast-paced environment.Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.Ability to verbally communicate ideas and issues effectively to other team members and management.Ability to write and record data and information as required by procedures.Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company). #LI-NJ1 #LI-HybridLicense and CertificationsRegulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferredTravel Requirements5%: Up to 13 business days per yearPhysical RequirementsSedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to View email address on click.appcast.io. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.