Regulatory Affairs Sr Specialist

Zimmer, Inc.•Jacksonville, FL

18h•Remote

About The Position

The Regulatory Affairs Sr Specialist supports regulatory processes for medical technology products, including assembling, distributing, storing, tracking, and retrieving regulatory information and authoring and publishing electronic submissions. The role prepares documentation for marketing approval in response to requests from foreign governments and distributors, provides routine regulatory information to associates and affiliates, and researches regulatory pathways for new or modified products. As a core member of development project teams, the specialist provides regulatory direction and develops strategies for new products, evaluates the risks of proposed strategies, and recommends solutions. The role reviews labeling, package inserts, promotion and advertising materials, and proposed product changes for regulatory compliance and impact on regulatory status. It also interprets and applies FDA regulations, advises organizational and design teams, and communicates with regulatory and governmental agencies. The role permits full-time remote work throughout the U.S. and requires up to 15% domestic travel.

Requirements

Bachelor’s degree in engineering management, engineering, life sciences, or a related field, or foreign equivalent; alternatively, the posting lists a master’s degree in these fields or a related field, or foreign equivalent.
Experience in the job offered or a related position: 5 years with a bachelor’s degree, or 3 years with a master’s degree.
At least 1 year of experience in the orthopedic or medical device industry.
At least 3 years of experience with FDA and EU regulations, including labeling regulations, and regulations outside the U.S. and EU.
At least 3 years of experience working with medical products and anatomic knowledge.
At least 3 years of experience interpreting and applying FDA regulations to business practices and providing regulatory input, advice, and guidance to organizations and design teams.

Responsibilities

Assemble, distribute, store, track, and retrieve information pertinent to regulatory processes, including submissions.
Author and publish electronic submissions.
Prepare and submit documentation for marketing approval in response to requests from foreign governments and distributors.
Provide routine regulatory information to associates and affiliates.
Research, analyze, and communicate information about regulatory pathways for new or modified products.
Provide regulatory direction to development project teams as a core team member and develop regulatory strategies for new products.
Evaluate risks of proposed regulatory strategies and offer solutions.
Review proposed labeling for compliance with applicable U.S. and international regulations.
Write, manage, and approve the development of package inserts.
Review, evaluate, and approve promotional and advertising materials for compliance with applicable regulations.
Review proposed product changes for their impact on regulatory status.
Interpret and apply FDA regulations to business practices and provide regulatory input, advice, and guidance to the organization and design teams.
Communicate with regulatory and governmental agencies.