Senior Regulatory Affairs Manager

1w1 week ago

CorDx

Atlanta, US · Full-time · $155,000 – $215,000

About this role

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, it delivers rapid testing and point-of-care medical device solutions for infectious diseases like COVID-19. The Senior Regulatory Affairs Manager leads regulatory submissions including 510(k) to FDA, ensuring compliance and guiding cross-functional teams.

Day-to-day involves preparing, reviewing, and submitting regulatory documents to FDA while managing the submission process for timely clearances. Ensure products comply with FDA regulations, ISO standards, and other requirements. Provide regulatory guidance to the R&D team throughout the product development life cycle.

Collaborate with internal stakeholders and external partners to align on regulatory strategies and project timelines. Represent the company in meetings with regulatory agencies as needed. Work in a cross-functional team environment at the cutting edge of technology, AI, and data science.

Stay updated on regulatory changes and communicate impacts to the organization. Conduct assessments for product changes and recommend pathways. Contribute to successful approval and launch of innovative medical devices, with opportunities for leadership in healthcare diagnostics.

Requirements

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

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 team during product development life cycle
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 ensure alignment on regulatory strategies and project timelines
Represent the company in meetings with regulatory agencies and external partners as needed