About The Role

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As a Regulatory Associate in the Medical Device Industry, you will be responsible for ensuring that the company's medical devices comply with all regulatory requirements. You will work closely with cross-functional teams to ensure that products meet regulatory standards and will be responsible for preparing, submitting and maintaining regulatory documentation. You will also be responsible for monitoring and communicating changes in regulations and standards to ensure compliance.

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Responsibilities

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• You will be responsible for ensuring compliance with all applicable regulations including Drug License, FDA, ISO, and other national and international regulations.
• You will be responsible for preparing and submitting regulatory documentation for new and existing medical devices, including MDR: 2017 submissions, 510(k) submissions, technical files, and other regulatory documents.
• You will assist in the development of regulatory strategies to support the company's product development goals.
• You will communicate with regulatory agencies as necessary, and will keep cross-functional teams informed of regulatory requirements and changes.
• You will monitor changes in regulations and standards, and will work with cross-functional teams to ensure compliance with new requirements.
• You will assist in preparing for and participating in regulatory compliance audits.
• You will assist in maintaining the company's quality system, including documentation control and management.
• You will be responsible for adverse event reporting as required by regulatory agencies.

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Required Qualifications

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• Knowledge of FDA regulations, ISO standards, and other international regulations related to medical devices.
• Experience with regulatory submissions and technical files.
• Strong written and oral communication skills.
• Ability to work in a fast-paced, dynamic environment.
• Detail-oriented with strong organizational skills.
• Ability to work collaboratively in a team environment.

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Required Skill Sets

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• Bachelor’s degree in a scientific or technical discipline (biomedical engineering, other engineering discipline).