| New job - Senior Regulatory Affairs Lead - Orlando, FL at Orlando, Florida, USA |
| Email: [email protected] |
| From: Raghuteja, W3Global [email protected] Reply to: [email protected] Hello , This is Raghu From w3global. Please find below job. I would like to submit your profile to my client and schedule the interview. Please let me know your interest. Title: Senior Regulatory Affairs Lead Location: Orlando, FL Duration : 12 months Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending country guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives and project strategy. Create detailed written regulatory plans that can be used to target domestic and international shipment dates. Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations. Review and approve advertising, promotional items and labeling for regulatory compliance. Identify potential regulatory approvals' risks based on changes in regulations, standards country specific issues or other unique characteristics of the project. Work with internal stakeholders (R&D, manufacturing, Market Regulatory Affairs) and external stakeholders (regulatory authorities) to mitigate those risks. Communicate application progress to internal stakeholders. Education/knowledge: Bachelors degree or equivalent internationally-acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry At least 5 years in the medical device and regulatory affairs fields Strong written, communication, and problem-solving skills Recent 510(k) and EU MDR experience, preferably with FDA eSTAR Keywords: rlang Florida New job - Senior Regulatory Affairs Lead - Orlando, FL [email protected] |
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| Fri Nov 15 23:34:00 UTC 2024 |