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Advise internal stakeholders (marketing, manufacturing, R&D etc.) regarding current/pending guidance, regulations to ensure regulatory strategy is in alignment with company objectives;
Deliver high quality regulatory documents to support global Health Authority submissions;
Manage and oversee training of Company employees on regulatory matters to ensure compliance with requirements;
Monitor external regulatory developments and communicate potential issues;
Leverage both technical and regulatory knowledge to mitigate risks;
Ensure the maintenance and improvement of ISO 13485 certified quality management system;
Provide strategies, guidance and training to teams and stakeholders on requirements of ISO 13485:2016 and 21CFR820;
Implement and maintain complaint handling and vigilance system;
Serve as a technical expert for all relevant medical device regulatory bodies (FDA, ISO, etc.) to ensure proper processes, policies, and procedures are in place to obtain and retain necessary regulatory approvals and compliance;
Assure all marketing, sales and other written materials and practices are in conformance with regulatory requirements;
Coordinate the CAPA projects and facilitate risk management sessions (FMEA);
Lead & support audit readiness activities for the site and report the results to management;
Ensure all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers at the site;