Senior Regulatory Affairs Manager (Onsite)
Company: CorDx
Location: San Diego
Posted on: February 21, 2026
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Job Description:
Job Description Job Description Who is CorDx? CorDx 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, CorDx delivers rapid testing and point-of-care medical
device solutions used in the detection of infectious disease such
as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx
is at the cutting edge of technology, artificial intelligence, and
data science with the goal of delivering diagnostic solutions to
some of the most critical questions in healthcare. Job Type: Full
time Job Title: Senior Regulatory Affairs Manager Location: Onsite
- Atlanta, or San Diego Position Summary: The Senior Regulatory
Affairs Manager will play a crucial role in leading and managing
the regulatory submissions for CorDx medical device products,
including 510(k) and submissions. This individual will ensure
compliance with all applicable regulations in the preparation of
the submissions to FDA, provide regulatory guidance to
cross-functional teams, and contribute to the successful approval
and launch of innovative medical devices. 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 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. 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) and 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.
Keywords: CorDx, Moreno Valley , Senior Regulatory Affairs Manager (Onsite), Science, Research & Development , San Diego, California
