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.
