Regulatory Affairs Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Prepare and manage clinical regulatory submissions for INSIGHTEC products in applicable markets.

• Evaluate clinical documents to ensure they meet regulatory standards.

• Analyze data and reports included in regulatory submissions to confirm scientific integrity, precision, and clarity.

• Act as the US Agent for Insightec.

• Oversee cross-functional processes that support Regulatory, Clinical, and post-marketing functions.

• Handle annual renewals for establishment registrations, device listings, and other necessary regulatory licenses.

• Assess customer complaints to determine their reportability in accordance with regulatory standards.

• Offer continuous regulatory support and evaluations for promotional materials.

• Keep the company informed about new standards, guidelines, regulations, and relevant standards to ensure compliance.

• Assist in external and internal audits at headquarters and across the globe.

• Collaborate with R&D, Clinical, Quality, and Marketing teams both locally and internationally.

• Adhere to Insightec's quality policies, procedures, standards, as well as privacy and safety regulations.

⛳️ Requirements

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

• Proficient project management skills.

• At least 6 years of practical experience with clinical submissions for medical devices, including IDE/IND, ITA/CTA, and EU CTAs.

• Excellent verbal and written communication abilities.

• Capability to work collaboratively with cross-functional global teams.

• Experience with Class III products is an advantage.

• Referral by an Insightec employee is considered a plus.

🏝️ Benefits

• Flexible work environment.

• Life-work balance philosophy.

• Competitive perks and benefits tailored to each region.

• Opportunities for professional growth and internal talent development.