CorDx
Senior Regulatory Affairs Manager (Onsite)
CorDx, San Diego, California, United States, 92189
Overview
Senior Regulatory Affairs Manager (Onsite) – Atlanta, or San Diego. The role will lead regulatory submissions for CorDx 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. Key Responsibilities
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 Requirements
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 Skills & Competencies
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 Benefits
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 Equal Opportunity Statement
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.
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Senior Regulatory Affairs Manager (Onsite) – Atlanta, or San Diego. The role will lead regulatory submissions for CorDx 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. Key Responsibilities
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 Requirements
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 Skills & Competencies
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 Benefits
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 Equal Opportunity Statement
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.
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