Job Description

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The Regulatory Affairs Manager will be responsible for drafting and filing documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations.

Responsibilities

• Draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations.
• Develop and implement regulatory strategies to achieve timely product approvals.
• Prepare and submit regulatory documents to relevant regulatory agencies (e.g. US, EU, Health Canada).
• Serve as primary point of contact with regulatory body, managing communications and addressing questions or concerns relative to product/project.
• Monitor and interpret changes in regulatory guidelines and standards and assess their impact on the company.
• Lead Regulatory communications to the broader organization on pertinent regulations updates.
• Ensure ongoing compliance with regulatory requirements, including post-market surveillance.
• Collaborate with R&D, PPM (product and project manager), QA, marketing, commercial, and other departments to integrate regulatory requirements into product development and commercialization.

Requirements

• Bachelor's degree and/or Master's in Biology, Chemistry, bio-engineering, or related scientific area.
• 5 years of medical device, IVD Regulatory Affairs experience, to include either 510(k) or PMA Notified Body (NB) submissions.
• Preference for a former regulatory agency reviewer or staff (e.g., FDA submission reviewer).
• Proficient in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
• Experience in direct communication with regulatory agencies.
• Regulatory review experience of promotional marketing materials, press releases, labeling, etc.
• Strong oral and written communication skills, as well as the ability to provide scientific presentations.
• Ability to compile data and summarize results.
• Continuous improvement-minded, familiar with balancing Quality and the need for efficiency.

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