Associate, Regulatory Affairs (Medical Devices)
- Manage, plan, prepare, and deliver both electronic and paper-based documents to support global regulatory registrations, renewals, tenders, customs, and related activities
- Coordinate the preparation and submission of medical device applications by providing timely and accurate regulatory information and documents, and follow-up closely on queries from inspection through approval
- Evaluate documents for accuracy, appropriateness, and consistency for various regulatory submissions
- Prepare and/or review letters of authorization, cover letters for registration certificates, declarations, powers of attorney, and other regulatory documents
- Perform and/or coordinate legalization, notarization, and apostille of regulatory documents as required
- Ensure compliance with current good documentation practices including but not limited to proof reading, formatting, indexing, record keeping, etc.
- Submit and manage applications for US FDA Certificates of Foreign Government (CFGs)
- Provide support to internal and external teams by addressing technical inquiries and supplying requested regulatory information
- Utilize and maintain various systems and/or tracking tools to ensure up to date information and traceability of all regulatory data/documentation
- Perform document filing and retrieval in accordance with company policies and procedures
- Effectively communicate with various teams and clients regarding the status of deliverables to ensure timely and satisfactory completion of tasks and expectations
- Participate in group meetings and provide tactical approaches to addressing issues of basic complexity
- Perform other duties as assigned
- Bachelor’s degree (Life Sciences or a regulatory related field preferred)
- Minimum 1 year of experience in Regulatory Affairs within the medical device industry (regulatory registrations/ submissions preferred)
- General knowledge of EU MDD/MDR, US FDA QSR, and ISO 13485 standards
- Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint
- Strong understanding of Good Documentation Practices (GDP) in a regulatory environment
- Excellent organizational skills with strong attention to detail, effective planning, and the ability to multitask efficiently
- Self-motivated and capable of working independently, as well as collaboratively, on projects of diverse scope requiring analytical evaluation of data and situations
- Excellent English communication skills, both written and verbal
- Detail-oriented with strong critical thinking and analytical abilities, focused on delivering high-quality results
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