Sr. Specialist Regulatory Affairs, Medical Devices

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per weekWho 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 Regulatory Affairs Sr. Specialist is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, Post Market Submissions, China NMPA Registrations, Technical Documentation for CE Marking, 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 Transfer Devices with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant mannerAuthor and review US, EU, South Korea, China and additional international submissions with guidance for new products, product changes and post-market updates as required to ensure timely approvals for market release and file maintenanceWorks with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulationsProvide leadership to product development teams for regulatory issues and questionsProvide support to market-released products as necessary, including reviewing labeling, promotional material, product/manufacturing process changes, post-market reporting and documentationEstablish and maintain good working relationships with agency personnelCompile and maintain regulatory databases or systems as well as technical documentation required for new or modified productsWrite or update standard operating procedures, work instructions, or policiesCleary and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customersDevelop 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 culturesChallenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive changeAdhere to all applicable government and West regulations, practices, and procedures to maintain complianceOther duties as assignedEducationEducation: Bachelor’s, Master’s degree or PhD in science, math, engineering, or related discipline or equivalent experience Work ExperienceBachelor’s with 5+ years; Master’s degree/PhD with 3+ years of medical device, pharmaceutical or regulatory experiencePreferred Knowledge, Skills and AbilitiesAble to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description Able to comply with the company’s safety and quality policy at all timesInternational regulatory competency Attention to detail with planning, time management and organizational skillsKnowledge of 21 CFR 820/ISO 13485Possesses technical leadership skills, as well as demonstrated understanding of related medical device and pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).Maintain working knowledge of computer software packages including MS Word, MS Excel, MS PowerPoint, Master Control, Adobe, SharePoint, MS Teams, Outlook, and others as requiredExperience directly interacting and presenting to project teams and customersStrong negotiation and decision-making skillsExcellent written and verbal communication, timeline management skillSelf-motivated with a proactive attitude and the ability to work effectivelyRegulatory compliance competency including Quality SystemsR.A.C certification(s)License and CertificationsRegulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferredTravel Requirements10%: Up to 26 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.Additional 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.#LI-DJ1 #LI-HYBRIDWest 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.