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Lead Regulatory Affairs Consultant
2 months ago
The Senior Regulatory Affairs Specialist will be responsible for crafting regulatory submissions for both domestic and international spinal product approvals. This role will also involve collaborating with spinal product design teams on change control processes and regulatory submissions.
Key Responsibilities:
1. Provide regulatory expertise on both domestic and international strategies for products, including spinal devices, software as a medical device (SaMD), and devices with integrated software, as well as radiation-emitting devices and cybersecurity considerations.
2. Support design control processes for spinal devices and related medical software, ensuring compliance with applicable regulations.
3. Implement IEC 62304 standards throughout the software development lifecycle for both domestic and international submissions.
4. Prepare and submit regulatory documents, including 510(k) premarket notifications to the FDA.
5. Maintain FDA establishment listings and registrations to ensure compliance.
6. Develop regulatory submissions, including technical files and design dossiers for spinal product registration in international markets, and engage with Notified Bodies regarding significant product changes.
7. Drive internal process enhancements, evaluate data and metrics, and maintain databases related to regulatory submissions for spinal products.
8. Assist in post-market surveillance evaluations, trend analysis, and reporting for spinal products, including updates to risk management processes.
9. Review labeling and promotional materials for spinal products to ensure alignment with regulatory approvals.
10. Conduct thorough research on regulatory information sources, including agency websites, standards organizations, and industry literature.
11. Provide support during internal and external regulatory audits.
12. Develop, maintain, and oversee company Standard Operating Procedures (SOPs) to ensure adherence to global regulatory requirements.
Qualifications:
A Master's degree or equivalent in Regulatory Affairs, Biomedical Engineering, Biology, or a related field, along with 2 years of relevant post-baccalaureate experience in a regulatory affairs role. Alternatively, a Bachelor's degree in a similar field with 5 years of relevant experience will be considered.
Experience must encompass the following areas, which may overlap: 2 years of experience with 510(k) submissions; 2 years with FDA Quality System Requirements (QSR) and ISO 13485; 2 years with MDD 93/42/EEC, MDR 2017/745, and New Zealand quality system requirements; 2 years with orthopedic or spinal devices; 2 years with medical devices containing software and SaMD; 2 years determining regulatory strategies for spinal or software-based medical devices; 2 years liaising with regulatory agencies and supporting audits; 1 year reviewing labeling and promotional materials; 1 year in process improvement under a quality management system; and 1 year maintaining FDA establishment registration and device listings.
