Sr. Specialist, Regulatory Affairs, Product Stewardship

This role is a remote role however candidates applying must be located within a 50 mile radius to any West location.

Who We Are:

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun.

A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

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.

• 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…