RA Intelligence Principal - Medical Device

 

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.  

Job Summary:

The Principal, Regulatory Affairs, Intelligence, Medical Device is expected to perform with minimal supervision and is an experienced and detail-oriented professional with expertise in medical devices with an understanding of combination products and containment systems. The successful candidate will play a crucial role in ensuring compliance with regulatory requirements for medical devices, including considerations for combination products and containment systems. This role requires a deep understanding of global regulatory frameworks, strong project management skills, and the ability to effectively collaborate with cross-functional teams and external vendors. This position includes supporting internal and external customer regulatory requests.

 

Essential Duties and Responsibilities:

• Perform surveillance activities by researching, identifying, and communicating up to date global medical device regulatory requirements that facilitate development, registration, submission and post marketing of West’s products and services.  Surveillance areas include, but are not limited to, medical devices, combination products, containment, labeling, packaging, and software.
• Research and articulate the latest regulatory intelligence to internal stakeholders and contextualize the impact on West portfolio and business.  Ensure that changes to applicable regulations are clearly and effectively communicated to drive action.
• Develop intelligence of emerging regulatory trends and communicate implications to internal stakeholders and external customers through updates to relevant portions of Master Regulatory Plan(s), trainings, presentations, white papers, etc.
• Monitor, analyze, and recommend action plans for current and future industry initiatives and draft public comments in response to regulations and guidance issued by regulators and health authorities.
• Collaborate with R&D, Quality Assurance, Clinical Affairs, and other departments to ensure alignment with regulatory requirements including but not limited to participating in project teams to provide regulatory guidance throughout the product lifecycle.
• Collaborate with and lead discussions with consultants and external vendors to assist in global regulatory strategies. Participate in industry events, conferences, or working groups, as applicable.
• Manage relationships, including subscriptions, with regulatory vendors, ensuring timely delivery of documentation and materials.
• Provide training to internal teams on regulatory requirements and updates related to medical devices and combination products.
• Maintain a high level of regulatory awareness through building influence through engagement in relevant trade associations, coalitions, and alliances.
• Other duties as assigned.