Sr. Specialist Regulatory Affairs, Medical Devices

Description

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week.

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 U.S. 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?

• The Regulatory Affairs Sr. Specialist is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, Post Market Submissions, 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.

• Develop and implement medical device regulatory strategies for West’s Transfer Devices with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
• Author and review US, EU, South Korea, China and additional international submissions with guidance for new products, product changes and post‑market updates as required to ensure timely approvals for market release and file maintenance.
• Works with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations.
• Provide leadership to product development teams for regulatory issues and questions.
• Provide support to market‑released products as necessary, including reviewing labeling, promotional material, product/manufacturing process changes, post‑market reporting and documentation.
• Establish and maintain good working relationships with agency personnel.
• Compile and maintain regulatory databases or systems as well as technical documentation required for new or modified products.
• Write or update standard operating procedures, work instructions, or policies.
• 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.
• 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.
• Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance.
• Other duties as assigned.

• Bachelor’s, Master’s degree or PhD in science, math, engineering, or related discipline or equivalent experience.

• Bachelor’s with 5+ years;
  Master’s degree/PhD with 3+ years of medical device, pharmaceutical or regulatory experience.

• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this…