E2 - Endovascular Engineering
Regulatory Affairs Manager
E2 - Endovascular Engineering, Menlo Park, California, United States, 94029
Endovascular Engineering (E2) is a mission-driven, venture funded medical device company dedicated to developing and deploying next-generation vascular thrombectomy solutions. Our innovative solutions aim to improve patient outcomes in pulmonary embolism and other vascular conditions. The company is in Menlo Park, CA.
Job Description
The Regulatory Affairs Manager is responsible for providing regulatory guidance for R&D project development teams and ensuring the implementation of regulatory strategy on the team level. The RA Manager compiles U.S. FDA regulatory submissions including Traditional and Special 510(k)s, Letters to File, IDE submissions and supplements, technical files for European Union submissions, and other regulatory filings as needed. The RA Manager shares Sr. Management the responsibility for compliance with US FDA regulations governing the distribution and sale of medical devices in the US and overseas. The RA Manager will review design control documents and change notification requests. The RA Manager maintains regulatory SOPs and work instructions updating those to be current with governing regulations, as needed. The RA Manager is an active member of design teams, providing regulatory guidance to the project team throughout the product development process. Responsibilities
Execute regulatory strategies/plans. Provide regulatory support for Product Development and Operations. Actively participate in project team meetings, work collaboratively with Project Managers, Quality Assurance, participate in Design Review, representing the RA strategy and its implementation. Prepare US and OUS regulatory filings, including IDE submissions in the US and Ethics Committee submissions in Europe and the ROW. Ensure the timely and accurate filing of regulatory documentation, mindful and consistent with company goals. Establish and maintain a professional relationship with regulatory bodies including FDA and Notified Body. Provide support for new and existing products. Develop in-depth understanding of product specifications, V&V requirements and Operation activities. Conduct regulatory review of proposed product changes and provide team guidance on the least burdensome approach. Perform labeling review for Advertising & Promotion. Preserve and maintain regulatory documentation consistent with 21 CFR820 and ISO 13485. Keep up to date on new regulation and guidance documents. Author and update procedures as required. Assist with facility inspections by regulatory agencies as required. Qualifications
5 years + experience working in the medical device industry. Experience submitting 510(k)s and IDE submissions and supplements to FDA. Experience working on R&D teams developing sterile, single-use disposable, medical devices, preferably pulmonary or cardiovascular interventions. Excellent communication skills, experience interacting with FDA. Works independently, recognizes opportunities, able to pivot and is comfortable working in a dynamic environment. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
The Regulatory Affairs Manager is responsible for providing regulatory guidance for R&D project development teams and ensuring the implementation of regulatory strategy on the team level. The RA Manager compiles U.S. FDA regulatory submissions including Traditional and Special 510(k)s, Letters to File, IDE submissions and supplements, technical files for European Union submissions, and other regulatory filings as needed. The RA Manager shares Sr. Management the responsibility for compliance with US FDA regulations governing the distribution and sale of medical devices in the US and overseas. The RA Manager will review design control documents and change notification requests. The RA Manager maintains regulatory SOPs and work instructions updating those to be current with governing regulations, as needed. The RA Manager is an active member of design teams, providing regulatory guidance to the project team throughout the product development process. Responsibilities
Execute regulatory strategies/plans. Provide regulatory support for Product Development and Operations. Actively participate in project team meetings, work collaboratively with Project Managers, Quality Assurance, participate in Design Review, representing the RA strategy and its implementation. Prepare US and OUS regulatory filings, including IDE submissions in the US and Ethics Committee submissions in Europe and the ROW. Ensure the timely and accurate filing of regulatory documentation, mindful and consistent with company goals. Establish and maintain a professional relationship with regulatory bodies including FDA and Notified Body. Provide support for new and existing products. Develop in-depth understanding of product specifications, V&V requirements and Operation activities. Conduct regulatory review of proposed product changes and provide team guidance on the least burdensome approach. Perform labeling review for Advertising & Promotion. Preserve and maintain regulatory documentation consistent with 21 CFR820 and ISO 13485. Keep up to date on new regulation and guidance documents. Author and update procedures as required. Assist with facility inspections by regulatory agencies as required. Qualifications
5 years + experience working in the medical device industry. Experience submitting 510(k)s and IDE submissions and supplements to FDA. Experience working on R&D teams developing sterile, single-use disposable, medical devices, preferably pulmonary or cardiovascular interventions. Excellent communication skills, experience interacting with FDA. Works independently, recognizes opportunities, able to pivot and is comfortable working in a dynamic environment. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr