Job Description

• The Regulatory Affairs Manager will draft and file documentation and submission materials for new and/or existing products to regulatory authorities in support of global product registrations.
• Regulatory Strategy Development: Develop and implement regulatory strategies to achieve timely product approvals.
• Submission Preparation: 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.
• Regulatory Intelligence: 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.
• Compliance Monitoring: Ensure ongoing compliance with regulatory requirements including post-market surveillance.
• Cross-functional Collaboration: 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:

• Bachelors degree and/or Masters 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 would be 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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