Regulatory Affairs Senior Specialist

What You Can Expect

How You'll Create Impact

• 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; develop regulatory strategy for new products.
• Evaluate risk of proposed regulatory strategies and offer solutions.
• Review proposed labeling for compliance with applicable US and international regulations.
• Write, manage, and approve the development of package inserts.
• Review, evaluation, 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 provide regulatory input, advice, and guidance to the organization and design teams.
• Communicate with regulatory and governmental agencies

What Makes You Stand Out

• Requires 5 years of experience in the job offered or related position.
• Requires 2 years of experience in orthopaedic or medical device industry.
• Requires 3 years of experience working with FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU. Requires experience with advanced anatomic knowledge.

Requires experience with the following:

• Knowledge of overall business environment, the orthopaedic industry and the marketplace;
• Relevant regulations pertinent to medical devices, biologics, drugs and combination products as applicable and
• Identifying risk in regulatory strategies.

Your Background

• Requires a Bachelor’s degree in Technical Engineering, Mechanical Engineering, or a related field, or a foreign equivalent.

Expected base salary of at least $108,701.00 per year depending on education and experience. 

Physical Requirements

Travel Expectations

• Requires up to 15% of domestic or international travel. Permits up to 100% remote work in the U.S.