West Pharmaceutical Services · 1 day ago
Senior Regulatory Affairs Specialist
Exton, PA
Full-time
Hybrid
Senior Level
5+ years expWest Pharmaceutical Services is a dedicated team committed to improving patient lives. The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, authoring submissions for medical devices, and ensuring compliance with regulations while mentoring team members.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
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
Qualification
Required
Bachelor's degree or equivalent experience is required
Minimum 5 years of relevant experience
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
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, 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)
Preferred
Master's degree or PhD in science, math, engineering, or related discipline preferred
2+ years of medical device regulatory experience preferred
Attention to detail with planning, time management and organizational skills
Regulatory compliance competency including Quality Systems
Experience with administration and safety systems preferred
Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
H1B Sponsorship
West Pharmaceutical Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (24)
2023 (18)
2022 (26)
2021 (17)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
President, CEO and Chair of the Board
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2025-12-06
Company data provided by crunchbase