Title:  Director, Regulatory Affairs - Medical Devices

What We Offer

Job Summary

The Regulatory Affairs Director is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory pre and post-market activities. The Director serves as a global regulatory lead for medical devices and RA business development, developing strategies for worldwide regulatory filings, preparing submissions, preparing submissions, including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking or those associated with NDAs, BLAs, MAAs.  The Director ensures timely and high-quality execution of all regulatory deliverables. In addition, the director manages other regulatory personnel and provides support for audits and inspections and 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

• Leadership role, managing team and driving submission process for product registration, submission and post marketing of medical device products
• Proactively gathers regulatory policy intelligence, analyzes changes in the regulatory environment, and works closely with internal subject matter experts to assess the impact of regulatory policies on West’s business goals
• Works with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations
• Directs, advises, and guides Regulatory Affairs sub-team members on regulatory strategies; anticipates, identifies, and communicates regional regulatory risks to sub teams, other departments/functions and advises of changes in regulatory guidance that may impact the business
• Ensures that all regulatory activities and documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance to facilitate agency review and acceptance
• Participate and/or oversee direct interactions with health authorities and external customers to achieve desired outcomes
• Foster career growth opportunities through training, mentorship and guidance of direct reports, RA staff and peers to define and achieve personal, departmental, and corporate objectives
• Manage and continue building the team to submit high quality support to West’s product portfolio and customers
• Actively participate with West’s internal and external customers to support development agreements pertaining to West’s medical device and combination product portfolio
• Liaise with regional regulatory submission facilitators to gain understanding of regional regulations

• Develop and maintain regulatory documentation databases or systems as well as technical documentation required for regulatory submissions and source documents
• Clearly and effectively communicate decisions, timelines, etc. to team and RA management.
• 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

Education

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

Work Experience

• Bachelor’s with minimum 10 years;  Master’s degree/PhD 5-6 years medical device, pharmaceutical or regulatory experience

Preferred Knowledge, Skills and Abilities

• Minimum US Class II, EU Class IIa device experience and in-depth knowledge of US FDA regulations (Title 21) and EU MDD (93/42/EEC) and MDR (2017/745)
• Advanced knowledge of 21 CFR 820/ISO 13485
• Possesses technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Experience interacting with government agencies
• Experience directly interacting and presenting to project teams and customers
• 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 written and verbal communication, timeline management and leadership skill
• Self-motivated with a proactive attitude and the ability to work effectively
• Regulatory compliance competency including Quality Systems
• Managerial experience #LI-NJ1 #LI-hybrid

License and Certifications

• Pharmaceutical and Medicine\Regulatory Affairs Certifications (RAC)-RAPS Upon Hire preferred

Travel Requirements

Physical Requirements

Additional Requirements

• 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. Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally.
• Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
• 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).