CorDx
Senior Regulatory Affairs Manager (Onsite)
CorDx, San Diego, California, United States, 92189
Overview
Job title: Senior Regulatory Affairs Manager (Onsite). Location: Onsite - Atlanta, or San Diego.
Position Summary The Senior Regulatory Affairs Manager will lead and manage regulatory submissions for CorDx medical device products, including 510(k) and De Novo submissions. This role ensures compliance with applicable regulations in preparing FDA submissions, provides regulatory guidance to cross-functional teams, and contributes to successful approval and launch of innovative medical devices.
Key Responsibilities
Prepare, review, and submit regulatory documents to the FDA.
Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
Ensure products comply with applicable regulatory requirements, including FDA regulations and ISO standards.
Provide regulatory guidance to R&D during 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.
Maintain proper documentation and correspondence of regulatory submissions with regulatory agencies.
Qualifications
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 obtaining 510(k) and De Novo 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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Position Summary The Senior Regulatory Affairs Manager will lead and manage regulatory submissions for CorDx medical device products, including 510(k) and De Novo submissions. This role ensures compliance with applicable regulations in preparing FDA submissions, provides regulatory guidance to cross-functional teams, and contributes to successful approval and launch of innovative medical devices.
Key Responsibilities
Prepare, review, and submit regulatory documents to the FDA.
Manage and oversee the regulatory submission process, ensuring timely and successful clearances/approvals.
Ensure products comply with applicable regulatory requirements, including FDA regulations and ISO standards.
Provide regulatory guidance to R&D during 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.
Maintain proper documentation and correspondence of regulatory submissions with regulatory agencies.
Qualifications
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 obtaining 510(k) and De Novo 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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