Sr. Specialist, Regulatory Affairs, Product Stewardship

West Pharmaceutical Services • Exton, PA

91d • Hybrid

About The Position

The Sr. Specialist, Regulatory Affairs evaluates supplier regulatory declarations for compliance, authors and maintains material compliance certifications, and responds to internal and external customer and/or agency regulatory requests. With 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.

Requirements

• Bachelor's Degree in science, math, engineering, or related discipline required
• Minimum 5 years Bachelor's with 5+ years required; or Master's degree/PhD 2+ years medical device regulatory experience required

Nice To Haves

• Master's Degree in science, math, engineering, or related discipline preferred
• PhD in science, math, engineering, or related discipline preferred
• 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

Responsibilities

• 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

What This Job Offers

• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees