Manager Regulatory Affairs

Job Title : Manager Regulatory Affairs

Job Location : Miami FL USA

Job Location Type : Remote

Job Contract Type : Fulltime

Job Seniority Level : MidSenior level

Job Title : Sr. Manager / Manager Regulatory Affairs Location : REMOTE US Department : Regulatory Affairs Reports To : Head of RA / QA US Company : InspireMD (Class III PMA Medical Device)

About Us

InspireMD is a dynamic growing company focused on developing and commercializing innovative Class III PMA and Class II medical devices. As we expand we are seeking a highly motivated Manager Regulatory Affairs to join our team. In this role you will be pivotal in managing both premarket and postmarket regulatory activities ensuring compliance with FDA regulations and overseeing regulatory submissions. You will have the opportunity to contribute significantly to the company’s growth working with crossfunctional teams to ensure regulatory success and maintain market access for our lifesaving products.

Job Summary

The Manager Regulatory Affairs will be responsible for managing regulatory affairs activities across the product lifecycle with a strong focus on both premarket and postmarket regulatory compliance for Class III PMA and Class II devices. You will be involved in regulatory submissions FDA site registration and product listing complaint handling and maintaining product approvals. This is a leadership role within a fastpaced startup where you will work closely with the R&D quality assurance and operations teams to ensure compliance with applicable FDA regulations and maintain successful product registration and market access.

Key Responsibilities

• Premarket Submissions : Manage and prepare regulatory submissions for new product approvals including PMA PMAS 510(k) submissions IDE applications and premarket notifications. Ensure compliance with FDA regulations and standards for Class III devices.
• Postmarket Compliance : Manage postmarket regulatory activities including maintaining product approvals managing product changes and ensuring compliance with FDA regulations. Coordinate and execute any necessary postmarket submissions.
• Complaint Handling : Lead the complaint handling process ensuring that all complaints are assessed investigated and documented in compliance with FDA requirements. Oversee the CAPA (Corrective and Preventive Action) process in collaboration with QA ensuring appropriate actions are taken in response to complaints.
• FDA Site Registration and Product Listing : Manage FDA site registration and product listing for the company’s medical devices. Ensure timely renewal and accurate maintenance of all registrations and listings in compliance with FDA requirements.
• Regulatory Strategy and Planning : Support the implementation of regulatory strategies for the US market collaborating with the R&D and quality teams to ensure smooth regulatory pathways for new products and product modifications.
• Crossfunctional Collaboration : Work closely with R&D quality assurance and operations teams to ensure alignment with regulatory requirements throughout the

product lifecycle. Provide regulatory guidance on labeling promotional materials and product changes.

Qualifications

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Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full Time

Vacancy : 1