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Regulatory Affairs Assistant Jobs in Decatur, GA

CorDx

Regulatory Affairs Manager (Atlanta)

Atlanta, GA · On-site

Regulatory Affairs Manager Location: Onsite - Atlanta, GA Position Summary: The Regulatory Affairs ... Stay current on changes in regulatory requirements and assist in assessing the impact on company ...

CorDx

Regulatory Affairs Manager (Atlanta)

Atlanta, GA · On-site

Regulatory Affairs Manager Location: Onsite - Atlanta, GA Position Summary: The Regulatory Affairs ... Stay current on changes in regulatory requirements and assist in assessing the impact on company ...

CorDx

Regulatory Affairs Manager (Atlanta)

Atlanta, GA · On-site

Regulatory Affairs Manager Location: Onsite - Atlanta, GA Position Summary: The Regulatory Affairs ... Stay current on changes in regulatory requirements and assist in assessing the impact on company ...

VERO BIOTECH INC

Participate in Quality Investigations to complete NCRs, Planned Deviations, and CAPAs. * Assist in ... Additionally, provide applicable problem-solving tools with required standards and regulations ...

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All JobsRegulatory Affairs JobsRegulatory Affairs Assistant JobsRegulatory Affairs Assistant Jobs in Decatur, GA

Regulatory Affairs Assistant information

See Decatur, GA salary details

$15

$33

$142

How much do regulatory affairs assistant jobs pay per hour?

As of Aug 17, 2026, the average hourly pay for regulatory affairs assistant in Decatur, GA is $33.78, according to ZipRecruiter salary data. Most workers in this role earn between $21.83 and $25.58 per hour, depending on experience, location, and employer.

What is a regulatory affairs assistant?

Regulatory Affairs Assistants are professionals who support regulatory affairs teams in ensuring that companies comply with all relevant laws and regulations related to their products, such as pharmaceuticals, medical devices, or food products. Their responsibilities typically include preparing and submitting documentation to regulatory bodies, maintaining records, tracking regulatory changes, and assisting in audits or inspections. They play a crucial role in helping organizations bring products to market efficiently and legally, while minimizing compliance risks. This entry-level position is foundational for a career in regulatory affairs and requires attention to detail, organizational skills, and an understanding of regulatory requirements.

What are the key skills and qualifications needed to thrive as a regulatory affairs assistant, and why are they important?

To thrive as a Regulatory Affairs Assistant, you need a solid understanding of regulatory guidelines, attention to detail, and a degree in life sciences or a related field. Familiarity with document management systems, regulatory submission software, and databases like eCTD is typically required. Strong organizational skills, effective communication, and the ability to work well under deadlines are essential soft skills. These competencies ensure accurate and timely submissions, compliance with regulations, and effective support of regulatory teams.

How does a regulatory affairs assistant typically interact with other departments within a company?

Regulatory Affairs Assistants often work closely with various departments such as research and development, quality assurance, and manufacturing. Their main responsibility is to help ensure that all product documentation and submissions comply with relevant regulations, which requires gathering information and coordinating updates from these teams. Effective communication and collaboration are essential, as Regulatory Affairs Assistants may attend cross-functional meetings and serve as a liaison to clarify regulatory requirements. This interdepartmental interaction helps streamline the approval process and ensures products meet compliance standards before reaching the market.

What is the difference between Regulatory Affairs Assistant vs Regulatory Affairs Specialist?

AspectRegulatory Affairs AssistantRegulatory Affairs Specialist
CredentialsTypically requires a bachelor's degree in life sciences or related fieldRequires a bachelor's degree, often with additional certifications or experience
Work EnvironmentSupports regulatory teams, handles documentation, and assists with submissionsLeads regulatory strategies, reviews submissions, and interacts with authorities
Industry UsageCommonly employed in pharmaceutical, biotech, and medical device companiesMore senior role, but overlaps in industry and employer types

The main difference is that Regulatory Affairs Assistants support and perform administrative tasks within regulatory teams, while Regulatory Affairs Specialists take on more responsibility in strategy, review, and communication with regulatory agencies. The Assistant role is often an entry-level position, whereas the Specialist role requires more experience and expertise.

What are the most commonly searched types of Regulatory Affairs jobs in Decatur, GA?

The most popular types of Regulatory Affairs jobs in Decatur, GA are:

What job categories do people searching Regulatory Affairs Assistant jobs in Decatur, GA look for?

The top searched job categories for Regulatory Affairs Assistant jobs in Decatur, GA are:

What cities near Decatur, GA are hiring for Regulatory Affairs Assistant jobs?

Cities near Decatur, GA with the most Regulatory Affairs Assistant job openings:

Regulatory Affairs Assistant jobs near you

Regulatory Affairs Manager (Atlanta)

CorDx

Atlanta, GA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 12 days ago

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: Regulatory Affairs Manager
Location: Onsite - Atlanta, GA
Position Summary:
The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.
Key Responsibilities:
  • Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies.
  • Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
  • Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements.
  • Stay current on changes in regulatory requirements and assist in assessing the impact on company processes and products.
  • Perform regulatory assessments for product changes and propose appropriate regulatory pathways.
  • Maintain documentation and records of all regulatory submissions and correspondence.
  • Support the preparation for regulatory agency meetings, audits, and inspections.
  • Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory deliverables are met in a timely manner.

Requirements
Education:
  • Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required.
  • Master's degree preferred.

Professional Experience:
  • 5-7 years of regulatory affairs experience within the medical device or IVD industry.
  • Working knowledge of 510(k) submissions and regulatory documentation processes.
  • Experience interacting with FDA and other regulatory agencies preferred.

Skills & Competencies:
  • Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and medical device regulatory requirements.
  • Strong organizational and project management skills with the ability to manage multiple projects and priorities.
  • Excellent communication, problem-solving, and attention to detail.
  • Ability to work collaboratively in cross-functional teams and manage document workflows.

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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