Principal Specialist, Regulatory Affairs

Description

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

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.

• Generous Paid Time Off (PTO):
  Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work‑life balance and recharge effectively.
• Global Career Opportunities:
  With facilities across North America, Europe, and Asia‑Pacific, employees have opportunities for international exposure and cross‑functional collaboration.
• 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.

The Principal Specialist, Regulatory Affairs (Medical Devices) is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, preparing global submissions including Premarket Notifications, Global Registrations, Technical Documentation for CE Marking, and Health Canada submissions. The Principal Specialist ensures timely and high‑quality execution of all regulatory deliverables. In addition, the Principal Specialist mentors team members, and provides support for global regulatory approvals (beyond US and EU), commercialized products, 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 administration and safety systems with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in the most efficient, compliant manner.
• Author and review complex product submissions guidance and negotiate submission issues with Agency personnel.
• Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations.
• Prepare US, EU, and other international submissions for new products and product changes as required to ensure timely approvals for clinical studies and market release.
• Work with RA team to build Regulatory strategies for medical device development platform.
• Prepare regulatory strategies/plans and worldwide requirement lists.
• Provide leadership to product development teams for regulatory issues and questions.
  
  Provide support to market‑released products as necessary, including review of labeling, promotional material,…