West Pharma Sr Specialist Regulatory Affairs Product Stewardship 

United States, Pennsylvania, West Whiteland Township 

4852443

Specialist, Regulatory AffairsWith minimal support, the Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables and ensures compliance with West and government requirements.This position includes leading the direct communication with suppliers and escalation to Category Managers. This role requires understanding and evaluation of impact of US and international regulations/guidelines/policies applicable to all West’s products (elastomers, devices, contract manufacturing, integrated systems) and services.

• Drive material compliance to applicable global product and/or packaging regulatory/environmental legislations (e.g. California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for all West global product portfolios
• With minimal support, develop compliance process including establishment of user requirements for tools supporting compliance process where applicable
• Lead, monitor and document communication with West’s suppliers requesting supplier documentation and/or questionnaires to support compliance with applicable regulations and customer inquiries
• Assist in development of digitalization and automation processes to improve efficiency in supplier compliance
• Monitor regulations, legislations and policies and provide regulatory guidance and communicate regulatory progress, decisions, strategies to cross functional teams
• Partner cross functionally within the organization (e.g. Procurement, D&T, Supplier QA) to drive efficiency, conformance and compliance
• Provide customers with West product compliance information and data as required for regulatory compliance and submissions to North America, Europe, and Rest of World agencies
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
• Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and Regulatory Affairs management
• Other duties as assigned

• Bachelor's Degree in science, math, engineering, or related discipline required or
• Master's Degree in science, math, engineering, or related discipline preferred or
• PhD in science, math, engineering, or related discipline preferred or
• Advanced degree preferred

• Minimum 5 years Bachelor’s with 5+ years required; or
• Master’s degree/PhD 2+ years medical device regulatory experience required

• Experience interacting with government agencies

• Knowledge of global material compliance regulations

• Able to comply with the company’s safety policy at all times

• Able to comply with the company’s quality policy at all times

• Able to work collaboratively across all levels of the organization to influence and persuade others

• Excellent written and verbal communication, timeline management and leadership skills

• Self-motivated with a proactive attitude and the ability to work effectively

• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures

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

• 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 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 build strong relationships both internally and externally
• Ability to work in a fast-paced environment
• 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).