Sr. Specialist Regulatory Affairs, Medical Devices

West Pharmaceutical Services • Uwchlan Township, PA

8d • Hybrid

About The Position

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, 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 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 Job Description
• Able to comply with the company’s safety and quality policy at all times
• Knowledge of 21 CFR 820/ISO 13485
• Possesses technical leadership skills, as well as demonstrated understanding of related medical device and pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS PowerPoint, Master Control, Adobe, SharePoint, MS Teams, Outlook, and others as required
• Experience directly interacting and presenting to project teams and customers
• Strong negotiation and decision-making skills
• Excellent written and verbal communication, timeline management skill
• Self-motivated with a proactive attitude and the ability to work effectively
• Regulatory compliance competency including Quality Systems
• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data.
• Ability to organize complex information and combine pieces of information to form general rules or conclusions.
• Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross- functional and/or matrix teams.

Nice To Haves

• International regulatory competency
• Attention to detail with planning, time management and organizational skills
• R.A.C certification(s)
• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

Responsibilities

• 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
• Cleary 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

Benefits

• Benefit programs
• Opportunities for lifelong learning, growth and development
• Support for physical, mental, emotional and financial health of team members and their families
• Giving back to communities
• Commitment to creating a healthier environment and planet through sustainability efforts

What This Job Offers

• Job Type: Full-time
• Career Level: Senior