Regulatory Affairs Senior Specialist

Zimmer, Inc.•Warsaw, IN

32d•Remote

About The Position

At Zimmer Biomet, team members contribute to the company’s mission of enhancing mobility and renewing lives through medical technology. This Regulatory Affairs Senior Specialist supports regulatory processes for medical devices and related products, including submissions, marketing approvals, product development, labeling, and promotional materials. The role provides regulatory guidance to development teams and the wider organization, assesses regulatory strategy risks, and communicates with regulatory and governmental agencies. The position permits up to 100% remote work in the U.S. and requires up to 15% domestic or international travel.

Requirements

Bachelor’s degree in Technical Engineering, Mechanical Engineering, or a related field, or a foreign equivalent.
At least 5 years of experience in the job offered or a related position.
At least 2 years of experience in the orthopaedic or medical device industry.
At least 3 years of experience working with FDA and EU regulations, including labeling regulations, and regulations outside the U.S. and EU.
Experience with advanced anatomic knowledge.
Knowledge of the overall business environment, the orthopaedic industry, and the marketplace.
Knowledge of regulations pertinent to medical devices, biologics, drugs, and combination products, as applicable.
Experience identifying risk in regulatory strategies.

Responsibilities

Assist with assembly, distribution, storage, tracking, and retrieval of information pertinent to the regulatory process, including regulatory submissions.
Author and publish electronic submissions.
Respond to requests from foreign governments and distributors by preparing and submitting documentation for marketing approval and providing routine regulatory information to associates and affiliates.
Assist with research, analysis, and communication regarding appropriate regulatory pathways for new or modified products.
Provide regulatory direction as a core team member on development projects 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.