Regulatory Affairs Specialist jobs in Elkhart, IN

• Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process.
• Author and publish electronic submissions.
• Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates.
• Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
• Provide regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
• Evaluate risk of proposed regulatory strategies and offers solutions.
• Review proposed labeling for compliance with applicable US and international regulations.
• Write, manage, and approve the development of package inserts.
• Review, evaluate, and approve promotion and advertising material for compliance with applicable regulations.
• Review proposed product changes for impact on regulatory status of the product.
• Follow Zimmer Biomet regulatory affairs policy and procedures.
• May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
• Communicate with regulatory and governmental agencies.

Requires a Bachelor’s degree in Regulatory Affairs, Engineering, or Life Sciences, or related field.

Requires 5 years of experience in the job offered or a related role.

Must have 3 years of experience in orthopaedic or medical device industry.

Must have 3 years of experience with FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU.

Must have 2 years of experience working with medical products and advanced anatomic knowledge.

Must have 2 years of experience with Interpreting and applying FDA regulations to business practices and providing regulatory input, advice, and guidance to the organization and design teams.

Position permits remote work throughout the U.S. Position requires up to 15% domestic travel.