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Title:  Sr. Specialist, Regulatory Affairs, Product Stewardship

Requisition ID:  60713
Date:  May 31, 2023

Exton, Pennsylvania, US

Department:  Regulatory Affairs

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.


At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

In this role, you will be responsible for coordinating, authoring, and managing material compliance certifications for West’s elastomeric and device product portfolios.  With minimal support, the Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables and ensures compliance with West and government requirements.  The Sr. Specialist supports raw material change controls, internal and external customer regulatory requests, R&D product development while maintaining knowledge of current US and international regulations/guidelines/policies applicable to West’s products and services.


Essential Duties and 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 West’s product portfolios
  • With minimal support, develop compliance process including establishment of user requirements for tools supporting compliance process where applicable
  • Manage change controls and determine impact to compliance statements
  • Monitor regulations, legislations and policies and provide regulatory guidance and communicate regulatory progress, decisions, strategies to cross functional teams
  • Create and provide documentation in response to customer regulatory requests which includes certifications, regulatory letters, technical packages, etc.
  • Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and RA management
  • Train, mentor and/or guide the activities of RA staff members and peers to define and achieve personal, departmental, and corporate objectives, as applicable
  • 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
  • Other duties as assigned

Basic Qualifications: 

  • Education:  Bachelor's, Master's degree or PhD in science, math, engineering or related discipline
  • Experience: Bachelors with 5-8 years; or Master's degree/PhD with 2+ years regulatory/pharmaceutical/material compliance experience
  • Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)
  • Attention to detail with planning, time management and organizational skills
  • Self-motivated with a proactive attitude and must be able to work effectively
  • Excellent interpersonal, communication and technical writing skills


Preferred Knowledge, Skills and Abilities:

  • Experience interacting with government agencies
  • Knowledge of the 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.


Travel Requirements:

  • Must be able to travel up to 5-10% of the time (meetings, trainings, projects, industry events), including international travel


Physical and Mental Requirements:

  • Sedentary environment: ability to work in an office; may need to stand or sit for extended periods of time
  • Must be able to communicate effectively, speak in front of groups, express & exchange ideas and understand direction.
  • Maintain the ability to work well with others in a variety of situations.
  • Able to multi-task, work under time constraints, problem solve, and prioritize.
  • Able to learn and apply new information or new skills.
  • 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)



West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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