Regulatory Affairs Manager

📋 Description

• Act as the US Agent for Insightec.

• Offer regulatory guidance for Clinical and Post-marketing operations related to INSIGHTEC products.

• Prepare and maintain clinical regulatory submissions and registrations for INSIGHTEC products across relevant markets.

• Evaluate clinical documents for regulatory compliance; perform reviews of data or reports intended for regulatory submissions to ensure scientific rigor, accuracy, and clear presentation.

• Manage and update annual renewals of Establishment Registrations, Device Listings, and other essential regulatory licenses.

• Assess customer complaints to determine reportability based on regulatory standards and execute reporting as needed.

• Provide continuous regulatory support and evaluations for Promotional materials.

• Assist with all external and internal audits at headquarters and globally, as required.

• Counsel project teams on premarket regulatory standards, labeling obligations, and other compliance matters.

• Collaborate closely with various INSIGHTEC teams (e.g., R&D, Clinical, Quality, Marketing) both locally and internationally, to deliver necessary regulatory input.

• Keep the organization informed about upcoming or new guidance, regulations, agency/industry initiatives, and other relevant standards to maintain ongoing regulatory compliance.

• Address other regulatory-related needs as required.

• Operate in accordance with Insightec's Quality Policy, relevant Quality Procedures & Standards, as well as privacy and safety regulations.

⛳️ Requirements

• Bachelor's degree in a scientific, technical discipline, or engineering.

• At least 6 years of experience in Regulatory Affairs with the US FDA and EU regulatory bodies.

• Practical experience with Class III medical devices, including IDE/IND, ITA/CTA, EU CTAs, PMAs, 510(k)s, and CE Mark submissions.

• Excellent verbal and written communication skills.

• Capability to work with cross-functional global teams.

🏝️ Benefits

• Competitive perks and benefits.