West Pharma Senior Specialist Regulatory Affairs 

United States, Pennsylvania, West Whiteland Township 

602516665

Sr. Specialist,Regulatory Affairs, Medicalis responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations,including Premarket Notifications and Technical Documentation for CE Marking. The Senior 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.

• 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

• Bachelor’s, Master’s degree or PhD in science, math, engineering, or related discipline

• 3-5 years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience
• Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
• History of successful international device registration, US 510(k) and/or EU technical documentation submissions

• Advanced knowledge of ISO 13485
• 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.

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

• 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 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.