Senior Regulatory Affairs Manager; Onsite

Overview

Senior Regulatory Affairs Manager (Onsite) – Atlanta, or San Diego. The role will lead regulatory submissions for Cor Dx medical device products (including 510(k) submissions), ensure compliance with applicable regulations, and provide regulatory guidance to cross-functional teams to support successful approvals and launches.

Position Type:
Full-time.

Location:

Onsite in Atlanta or San Diego.

• Prepare, review, and submit regulatory documents to FDA
• Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals
• Ensure that all products comply with applicable regulatory requirements, including FDA regulations and ISO standards
• Provide regulatory guidance to R&D teams during the product development lifecycle
• Stay updated on changes in regulatory requirements and communicate potential impacts to the organization
• Conduct regulatory assessments for product changes and provide recommendations for appropriate regulatory pathways
• Collaborate with internal stakeholders and external partners to align regulatory strategies and project timelines
• Represent the company in meetings with regulatory agencies and external partners as needed
• Ensure proper documentation and maintenance of regulatory submissions and correspondence with regulatory agencies

• Master’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related field; advanced degree preferred
• Minimum of 7-10 years of experience in regulatory affairs within the medical device industry
• Proven track record of leading and successfully obtaining 510(k) clearances/approvals
• Experience in interacting with FDA and other regulatory agencies

• In-depth knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and other applicable medical device regulations
• Strong leadership and project management skills, with the ability to manage multiple projects and priorities
• Excellent communication, negotiation, and problem-solving skills
• Ability to work collaboratively in a cross-functional team environment
• Detail-oriented with strong organizational skills

• Highly competitive compensation package
• Comprehensive medical, dental, and vision insurance
• 401(k) plan with generous company contributions
• Flexible paid time off (PTO) policy
• Additional substantial benefits

We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.