Senior Regulatory Affairs Specialist

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This is a hybrid position that requires the team member to be onsite at least 3 days per week at our Exton, PA office. No relocation is provided.

The Senior Specialist, Regulatory Affairs, Medical is responsible for influencing departmental regulatory processes, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages.

• 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, including 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.

• Bachelor’s degree or equivalent experience is required.
• Master’s degree or PhD in science, math, engineering, or related discipline preferred.

• Minimum 5 years of relevant experience.
• 2+ years of medical device regulatory experience preferred.
• Experience with US FDA regulations (Title 21 CFR 820), 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.

• 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.

• Ability 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,…