Senior Regulatory Affairs Specialist

West Pharmaceutical Services • Exton, PA

90d • Hybrid

About The Position

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. 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. This position includes supporting internal and external customer regulatory requests.

Requirements

• Bachelor's degree or equivalent experience is required.
• Minimum 5 years of relevant experience.
• 2+ years of medical device regulatory experience preferred.
• Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745).
• History of successful international device registration, EU MDR technical documentation and/or US 510(K) authoring experience.
• Advanced knowledge of ISO 13485.
• Advanced knowledge of product life cycle, product development process, design control and change control.
• Experience interacting with government agencies.
• Excellent oral communication, technical writing, and decision-making skills.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Opportunities for lifelong learning, growth and development.
• Support for physical, mental, emotional and financial health of team members and their families.
• Commitment to giving back to communities.
• Sustainability efforts.

What This Job Offers

• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree