Title:  Senior Specialist, Regulatory Affairs

Job Summary

The Senior Specialist, Regulatory Affairs is expected to understand development of medical devices as applicable to combination products. To ensure, with minimal supervision, regulatory strategies are applied to regulatory submission documents to meet program requirements including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking or those associated with NDAs, BLAs, MAAs.  In addition, the Sr. Specialist ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

Essential Duties and Responsibilities

• Implement regulatory strategies for medical devices and combination products with an emphasis on gaining regional regulatory approval/clearance/license
• Prepare US, EU, and international submission sections (510k, IND, CTA, IMPD, NDA, BLA, MAA, etc.) for new products, product changes and information requests as required to ensure timely approvals for clinical studies and market release throughout the product life-cycle
• Author and review product submissions and assist with submission strategy and issues with regulatory bodies
• Provide guidance to global cross-functional teams to ensure documentation is accurately prepared with consideration to scientific rigor, accuracy, and clarity of presentation to support high quality global regulatory submissions
• Review change controls to determine impact and reportability to existing regulatory filings
• Supports EU RA office with complaints and Post Market Surveillance of marketed products
• Maintain proficiency in worldwide regulatory requirements and establish and maintain good working relationships with agency personnel
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
• Other duties as assigned

Education

• 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

Work Experience

• Minimum 5 years of experience with Bachelor’s degree or
• Minimum 2 years of experience with Master’s degree/PhD in medical device regulatory required 

Preferred Knowledge, Skills and Abilities

• US Class II and EU Class IIa device experience and knowledge of US FDA regulations (Title 21), EU MDD (93/42/EEC) and MDR (2017/745), 21 CFR 820, 210, 211 and ISO 13485
• Knowledge of drug / device combination product global regulations and guidance’s
• Understanding of product life cycle, product development process, design control and change control
• Experience with interactions with government agencies
• Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)
• Strong negotiation and decision-making skills
• Excellent oral communication and technical writing skills
• Experience with combination product delivery systems
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times #LI-NJ1 #LI-hybrid

License and Certifications

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

Travel Requirements

Physical Requirements

Additional Requirements

• Ability to work in sedentary environment, in an office; may need to stand or sit for extended periods of time
• Ability to communicate effectively, speak in front of groups, express & exchange ideas and understand direction
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams
• 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 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 flexible with changing priorities and comply with constantly changing regulatory procedures
• Maintain working knowledge of computer software packages including eCTD, MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint and others as required