Director, Regulatory Affairs - Medical Devices

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

No relocation is provided for this opportunity

 

 

Who We Are:

 

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 US 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?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

What We Offer

Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.

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