Regulatory Affairs Sr Specialist

What You Can Expect

• Assist with the 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 and develop 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.
• Interpret and apply FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams.
• Communicate with regulatory and governmental agencies.

How You'll Create Impact

What Makes You Stand Out

Requires a Bachelor’s degree in engineering management, engineering, life sciences, or related field, or foreign equivalent.

Must have 5 years of experience in job offered or related position.

Requires 1 year of experience with Orthopedic or medical device industry.

Requires 3 years of experience with the following:

• Knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU.
• Working with medical product and anatomic knowledge.
• Interpreting and applying FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams

Your Background

Requires a Master’s degree in engineering management, engineering, life sciences, or related field, or foreign equivalent.

Must have 3 years of experience in job offered or related position.

Requires 1 year of experience with Orthopedic or medical device industry.

Requires 3 years of experience with the following:

• Knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU.
• Working with medical product and anatomic knowledge.
• Interpreting and applying FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams.

Role permits full-time remote work throughout the U.S.

Physical Requirements

Travel Expectations

• Role requires up to 15% domestic travel.