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Regulatory Associate Jobs in Decatur, GA (NOW HIRING)

Werfen

Regulatory Associate

Norcross, GA · On-site

Overview Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations ...

Werfen

Regulatory Associate

Norcross, GA · On-site

Overview Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations ...

Werfen

Regulatory Associate

Norcross, GA

Overview Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations ...

Werfen

Regulatory Associate

Norcross, GA

Overview Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations ...

Werfen

Regulatory Associate

Norcross, GA · On-site

Job Summary The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations, labeling ...

Optimum Results Staffing

Corporate Associate

Atlanta, GA

$160K - $220K/yr

Corporate Associate Location: New York, NY & Atlanta, GA Salary Range: $160,000 - $220,000 per year ... This role involves drafting contracts, conducting due diligence, and advising clients on regulatory ...

SUPPLY.com

Warehouse Associate - Entry Level

Mcdonough, GA · On-site

$14.50 - $17.25/hr

Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...

HP Products

Warehouse Associate - Entry Level

Mcdonough, GA · On-site

$14.50 - $17.25/hr

Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...

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How much do regulatory associate jobs pay per hour?

As of May 31, 2026, the average hourly pay for regulatory associate in Decatur, GA is $31.45, according to ZipRecruiter salary data. Most workers in this role earn between $23.94 and $37.31 per hour, depending on experience, location, and employer.

What Does a Regulatory Associate Do?

As a regulatory associate or regulatory affairs associate, your job is to coordinate compliance with internal—and occasionally external—regulations. This work involves checking each inspection review for accuracy, using safety data sheets (SDS), gathering and compiling documentation for products, and submitting material for license renewals and registrations. In this role, you often create management templates, study existing report documents, oversee the collection of consent forms, and audit the company for any sign of regulatory noncompliance. Some regulatory associates frequently travel to perform audits at various locations. Depending on the industry, you may have additional tasks that involve meeting state or federal guidelines.

What are the key skills and qualifications needed to thrive as a Regulatory Associate, and why are they important?

To thrive as a Regulatory Associate, you need strong attention to detail, knowledge of regulatory guidelines (such as FDA or EMA), and a relevant degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and electronic common technical document (eCTD) software is typically required. Excellent organizational skills, communication abilities, and the capacity to manage deadlines make candidates stand out. These skills ensure accurate regulatory submissions, compliance with evolving regulations, and effective collaboration across teams, all of which are crucial for product approvals and market access.

What are some common challenges Regulatory Associates face when working with cross-functional teams?

Regulatory Associates often work closely with teams from R&D, quality assurance, clinical, and legal departments to ensure compliance throughout product development and approval processes. A common challenge is navigating differing priorities and timelines among these groups, which requires strong communication and organizational skills. Additionally, Regulatory Associates must interpret and clarify complex regulatory requirements to various stakeholders, ensuring everyone is aligned and informed. Building collaborative relationships and proactively addressing potential misunderstandings are key to overcoming these challenges.

What is a Regulatory Associate?

A Regulatory Associate is a professional who supports regulatory affairs teams in ensuring that a company complies with all relevant laws and regulations, particularly in industries like pharmaceuticals, biotechnology, and medical devices. They assist in preparing, submitting, and maintaining regulatory filings and documentation required by government agencies. Regulatory Associates also help track changes in regulations and support product development by ensuring all necessary approvals are obtained for products to enter the market.

What is the difference between Regulatory Associate vs Compliance Specialist?

AspectRegulatory AssociateCompliance Specialist
Required CredentialsBachelor's degree in life sciences, regulatory affairs, or related field; certifications like RAC are a plusBachelor's degree in law, business, or related; certifications like CCEP may be relevant
Work EnvironmentPharmaceutical, biotech, or medical device companies; regulatory departmentsCorporate compliance departments across various industries, including healthcare and finance
Employer & Industry UsageUsed in regulated industries to prepare and submit regulatory documentsUsed to ensure company adherence to laws and regulations, often involving audits and policy development

The Regulatory Associate primarily focuses on preparing and managing regulatory submissions within life sciences industries, while the Compliance Specialist ensures ongoing adherence to laws and regulations across various sectors. Both roles require similar educational backgrounds and certifications, but their core responsibilities and work environments differ slightly, with Regulatory Associates working more directly with regulatory agencies and Compliance Specialists focusing on internal compliance processes.

More about Regulatory Associate jobs
What are the most commonly searched types of Regulatory jobs in Decatur, GA? The most popular types of Regulatory jobs in Decatur, GA are:
What job categories do people searching Regulatory Associate jobs in Decatur, GA look for? The top searched job categories for Regulatory Associate jobs in Decatur, GA are:
What cities near Decatur, GA are hiring for Regulatory Associate jobs? Cities near Decatur, GA with the most Regulatory Associate job openings:
Regulatory Associate jobs near you
Regulatory Associate

Regulatory Associate

Werfen

Norcross, GA • On-site

Full-time

Posted 14 days ago

Werfen rating

8.7

Company rating: 8.7 out of 10

Based on 27 frontline employees who took The Breakroom Quiz

Job description

Introduction
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Overview
Job Summary
The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations, labeling change requests and tracking of field action alert documentation. Additionally, this position will support the preparation and submission of supplements and amendments to FDA for approval, which includes responding to deficiency letters. This role will also support other team members, as needed. Performs tasks that support quality system compliance with US FDA Quality System Management Regulation (21 CFR 820) and biologic regulations (21 CFR 600-680), Canadian Medical Devices Regulations (SOR/98.282), In- Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, ISO 13485:2016 and other applicable international medical device regulations.
Responsibilities
Key Accountabilities
  • Routes labeling change requests for revisions to current products.
  • Proofreads labeling drafts as requested.
  • Prepares and submits Annual Reports, PMS reports, Medical Device Reports (MDRs), amendments, and other correspondences, as needed.
  • Supports the collection of documents for foreign registrations.
  • Provides general support to regulatory team members
  • Recognize and elevate critical regulatory/compliance issues to RA management.
  • Assist with preparation of documentation for regulatory and third-party inspections.
  • Support regulatory tracking, archival, and information management activities.

Networking/Key relationships
Works closely with other Regulatory Affairs members, quality assurance, manufacturing, customer service, shipping, sales and marketing staff.
Qualifications
Minimum Knowledge & Experience required for the position:
Education:
  • Bachelor's degree in science, engineering or related field required.

Experience:
  • Minimum of 1-3 years of experience in the US, EU, and international regulatory affairs within the medical device industry required.

Skills & Capabilities:
  • Knowledge of and experience with FDA medical device and/or biologics regulations and guid-ance, Regulation (EU) 2017/745 or 2017/746 (IVDR) and guidance, Good Clinical Practices guidance, ISO 13485:2016 Quality System standards, ISO 14971:2019 Risk Management, and other applicable US and international regulations, guidances, and standards, preferable.
  • Ability to manage multiple task and deadlines.
  • Works precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality.
  • Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

Travel requirements:
N/A
Closing
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
www.werfen.com

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About Werfen

Sourced by ZipRecruiter

Industry

Health care and social assistance

Company size

1,001 - 5,000 Employees

Headquarters location

L'Hospitalet de Llobregat, Barcelona, ES

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