Job Description

• Prepare and submit regulatory documentation for domestic and international markets, ensuring compliance with applicable regulations (i.e. PMA, HDE, 510ks, letters to file, and Tech Docs).
• Provide regulatory direction to development project teams as a core team member.
• Develop regulatory strategy for new products, evaluating risk of proposed strategies and offering solutions.
• Review proposed labelling for compliance with applicable global regulations.
• Review proposed product changes for impact on regulatory status of the products.
• Contribute to the development and maintenance of Instructions for Use and Surgical Technique Guides.
• Review and evaluate promotion and advertising material for compliance with applicable regulations.
• Communicate with regulatory and governmental agencies.
• May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.
• Support additional regulatory compliance items as required by regulations and as needed by the RA team.
• May provide training and/or guidance to entry-level associates, analysts, interns, and specialists.

• Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred.
• (Preferred) Minimum of 2 years of experience in orthopaedic or medical device industry.
• (Required) A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field.
• Combination of education and experience may be considered.
• Strong writing, communication, and interpersonal skills.
• Strong attention to detail.
• Able to multi-task and balance competing priorities, and willingness to work with changing priorities.
• Knowledge of overall business environment, ideally within the orthopedic industry.
• Eager to build relationships between Regulatory Affairs and other teams within the organization.
• Ability to communicate effectively at all levels.
• Advanced knowledge of FDA, EU, and other regulatory body regulations.

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