Quality assurance (QA) and regulatory affairs (RA) are at the center of safe, effective products worldwide. They hold products to a high standard and support compliance, particularly in industries like life sciences, biotechnology, medical technology and diagnostics. Together, quality and regulatory affairs teams safeguard a company’s operation and what it produces.
With innovation increasing across molecular diagnostics, connected medical devices and cell and gene therapies, more organizations are investing in QA and RA talent, making it an excellent time to work in this field.
This guide is for job seekers who want to learn more about quality assurance and regulatory affairs jobs. We’ll explore common and in-demand roles and what these positions entail, including day-to-day responsibilities and salary insights. We’ll also look into the future, discussing the quality assurance and regulatory affairs career outlooks, so professionals know what to expect.
Table of Contents
- What Are Quality Assurance and Regulatory Affairs?
- Quality Assurance and Regulatory Affairs Job Description
- Popular Quality Assurance and Regulatory Affairs Jobs
- Regulatory Affairs and Quality Assurance Salary Insights
- The Future of Quality Assurance and Regulatory Affairs Jobs
- Tips for QA and RA Job Seekers
- Advancing the Future of Human Health at Danaher
- Explore Quality and Regulatory Affairs Jobs at Danaher
What Are Quality Assurance and Regulatory Affairs?
Quality assurance builds and runs the systems that keep products consistent and safe, while regulatory affairs charts the path to market and keeps products compliant.
Together, QA and RA teams ensure safe, effective, traceable and legally marketable drugs and medical products. QA builds and operates the systems that create consistent, verifiable quality, while RA translates those systems for regulatory compliance and market authorization.
These roles are important for more than just meeting legal obligations. They also help build trust with patients, health care providers and regulatory agencies worldwide.
Quality Assurance
To better understand QA, think of policies, procedures, training, audits and metrics. Teams carry out each of these processes with every single product they develop, diligently following the steps to deliver a safe, effective and reliable product every time.
They foresee and take action to prevent potential issues. QA professionals are also responsible for generating evidence that products and procedures meet quality requirements.
Their quality management system (QMS) typically aligns with standards like Good Manufacturing Practice (GMP) and the International Organization for Standardization (ISO) to ensure high-quality products.
Regulatory Affairs
RA teams ensure drugs and medical products stay compliant at all steps of development, from testing to distribution. They interpret regulations regarding the specific product being developed, choose approval pathways, prepare submissions and ensure compliance through each process.
They work closely with scientists, engineers and legal experts to make sure products meet regulatory standards, essentially serving as the liaison between the industry and regulatory bodies.
Quality Assurance and Regulatory Affairs Job Description
While some companies hire QA and RA as separate roles, many combine them to build critical functions — developing safe, effective products and ensuring they comply with relevant sales and marketing laws.
Typical quality and regulatory affairs job duties include:
- Oversee the QMS: Quality assurance regulatory affairs professionals must develop, implement and oversee the company’s QMS, making sure processes and documentation comply with regulations like ISO.
- Guide product development: Professionals work directly with research and development (R&D) teams to meet quality requirements and follow the correct regulatory pathways. Together, they make sure all new products are designed to be effective and approvable from the start.
- Manage all product-related documentation: Quality assurance and regulatory affairs include approving critical documents like design specifications and manufacturing and testing protocols. These documents serve as proof of quality and evidence when submitting to regulations.
- Lead risk management activities: This involves conducting risk assessments throughout the product life cycle. These tests can spot potential quality issues. Quality assurance and regulatory affairs professionals will help their company mitigate quality problems so that all products are acceptable for regulatory agencies.
- Manage change control: Part of the job includes evaluating any proposed changes to products or processes. Professionals must think about how these changes could affect the product’s quality. At the same time, they also need to determine if a change would require notifying or making a new submission to a regulatory body.
- Qualify and monitor suppliers: Quality assurance and regulatory affairs teams audit and approve suppliers of raw materials and components. The goal is to ensure products meet the company’s specifications and that the suppliers themselves comply with the correct regulations.
- Oversee batch review and product release: Another critical aspect of the job is doing a final review of all production records before releasing batches for sale. Professionals must confirm that the products meet quality standards and were manufactured in full compliance with the approved regulatory file.
What are you looking for in potential applicants?
“Individuals who have a quality or regulatory background, preferably within med device, biotech or pharma who have worked in a regulated environment (most commonly ISO 9001 or 13485).”
Senior Talent Advisor, Danaher
Popular Quality Assurance and Regulatory Affairs Jobs
With innovation, changing regulations, and a growing focus on product quality and safety, quality assurance and regulatory affairs jobs are more in demand than ever. Common roles and tasks in this industry include:
1. Quality Assurance Specialist
QA specialists play an important role in a product’s effectiveness and safety. They create protocols for designing and inspecting products, while also carrying out training and audits to ensure the company meets quality standards. Main duties include:
- Creating quality protocols and training: QA specialists create the plans, procedures and checklists for inspecting products. They also educate other teams on quality control procedures, making sure everyone works together to develop the highest-quality products for customers.
- Conducting audits and inspections: These experts also carry out inspections and audits in their day-to-day roles. They inspect raw materials, check up on items during production, and then review final deliverables, making sure products are safe and effective.
- Troubleshooting and resolving issues: If a quality issue arises throughout a product’s life cycle, the quality assurance specialist is responsible for determining its root cause. They then must work with other teams to fix it and prevent the issue from occurring in the future.
- Documenting and reporting: An important part of the job involves recording daily quality tasks. For instance, specialists record all testing procedures and their results. They monitor for defects and record a product’s overall quality performance.
- Ensuring compliance: QA specialists are responsible for ensuring products meet the company’s quality standards, industry regulations and legal requirements.
A typical day for a QA specialist might start with reviewing production records and walking the manufacturing floor to observe the processes in action. They may then participate in meetings with other teams, discuss audit findings or collaborate with engineers to resolve a noncompliance.
Over time, QA specialists might advance to senior specialists or quality engineering roles. Some move into a leadership position, such as the QA manager.
2. Regulatory Affairs Associate
Regulatory affairs associates serve as the company’s liaison and trailblazers for market access, turning complex regulatory rules into clear, on-time submissions. They connect product teams with organizations like the Federal Drug Administration (FDA) or European Union (EU) notified bodies to keep launches on track and labels compliant across markets.
Typical responsibilities include:
- Preparing and submitting documentation: This important liaison arranges a product’s quality documentation and submits it to regulatory agencies for approval. They work with other team members, like quality assurance specialists, to organize records and get everything ready for submission.
- Monitoring changes in regulations: The regulatory affairs associate stays up to date on regulatory changes, understanding how each one could affect the company and its products. They interpret regulatory statutes and laws across different regions, including the FDA, EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) and Health Canada requirements. They then work across teams, like R&D, to update processes and make sure all testing programs and labeling comply with changing regulations.
- Providing strategic guidance: These professionals develop regulatory strategies for new and existing products. They also help prepare products for commercialization and guide the company through the approval process.
- Liaison support: Regulatory affairs associates contact government agencies. They answer questions about products and processes and arrange inspections or audits as needed.
- Internal support: Professionals manage their company’s regulatory databases and can also train colleagues on compliance protocols.
3. Quality Assurance Manager
Quality assurance managers develop and enforce the quality of products and services a company provides. They architect the QMS, coach teams to execute it and use data to lift performance on every build and batch.
These professionals maintain the frameworks for sampling, inspection and continuous improvement, so products ship right‑first‑time and audits run smoothly. The role involves responsibilities like:
- Developing procedures and standards: A successful QA manager designs, implements and maintains the standards and protocols that meet the company’s organizational goals and policies. This might mean developing testing structures, creating policy manuals or implementing feedback to help the company continuously improve.
- Performing regular audits: Audits are crucial for maintaining high-quality and effective products and services. A QA manager might help schedule and execute these audits, monitoring each step for discrepancies and recommending improvements.
- Managing teams: Quality assurance is all about collaboration. QA managers might be tasked with leading teams, making sure they understand the importance of their roles and creating a space where all members are set up to achieve quality benchmarks.
- Training staff: QA managers train new and existing staff on quality standards. They create training programs and promote continuous learning to ensure compliance with industry regulations and laws.
“Candidates pursuing a career in Quality and Regulatory Affairs at Danaher not only gain exposure to cutting-edge technologies and global regulatory standards, but also benefit from long-term development opportunities across Danaher’s diverse portfolio of operating companies. As part of a performance-driven culture, employees are encouraged to grow their expertise, take on new challenges, and explore roles in other business units, enabling continuous learning and career progression within the broader Danaher ecosystem.”
Talent Advisor, Danaher
4. The Regulatory Affairs Director
The regulatory affairs director is a company’s chief navigator for market access, turning complex and changing regulations into clear routes that get products to patients faster. They strategize and deploy policies that can fulfill business objectives without compromising compliance.
The following are common responsibilities for a regulatory affairs director:
- Formulating regulatory policies: Regulatory affairs directors make policies and guide life cycle changes. The proactive approach keeps company processes and products in line with domestic and international regulations.
- Managing regulatory submissions: The RA director’s key responsibility is overseeing regulated products’ life cycles, from approval to post-marketing changes, to stay updated and compliant.
- Cross-departmental collaboration: RA directors work closely with different departments, such as R&D, quality assurance, clinical, manufacturing and marketing. This allows a smooth production flow. Their guidance keeps products aligned with company objectives and approved, compliant and tested in every market.
Regulatory Affairs and Quality Assurance Salary Insights
Much like the setting and scope of a regulatory job, regulatory salaries can vary depending on the role, experience, location and company size. And as market demand increases, employers are willing to pay more for the right level of skill.
The average salary in the U.S. for regulatory affairs and quality assurance professionals includes:
- Quality assurance specialist: QA specialists can expect to make around $71,000 yearly.
- Regulatory affairs associate: In general, a regulatory affairs associate averages around $82,000 annually.
- Quality assurance manager: QA managers can typically earn up to $118,000 a year.
- Regulatory affairs director: RA directors can command an average yearly salary of about $176,000 to $248,000 or more.
Note that compensation varies with more than title. Annual bonuses, equity or long-term incentives at the senior levels can shape average salaries.
Product complexity, such as premarket approval (PMA) or Biologics License Application (BLA)-level evidence, and global scope can also influence salaries. Certain certifications, like Regulatory Affairs Certification (RAC) or American Society for Quality (ASQ) credentials, plus experience with International Organization for Standardization (ISO) 13485, ISO 9001, Canadian Medical Devices Regulations (CMDR) or FDA, can lift the ranges as well.
The Future of Quality Assurance and Regulatory Affairs Jobs
Professionals will find numerous opportunities to break into quality assurance and regulatory affairs positions. As the life sciences and medical technology sectors grow, the demand for skilled professionals in these fields will also rise. Trends shaping this outlook and making these roles more important than ever include:
Rapid Innovation in Biotech and Medical Devices
With speedy innovations in biotech, diagnostics and medical devices, there’s a need for more robust quality and regulatory oversight.
New therapies, advanced diagnostics and digital health solutions are entering the market faster than ever, with each breakthrough bringing new regulatory requirements and quality standards to uphold for patient safety and product effectiveness.
As a result, more companies need professionals with the skills to help them navigate these regulations and bring products and medications to market faster and more responsibly.
Increasing Complexity of Global Regulations
Global regulations are becoming more complex, with the FDA, EMA and other regulating bodies constantly updating their guidelines to keep up with scientific advancements.
With changing regulations comes more organizations needing regulatory affairs experts to interpret the rules, anticipate changes and devise strategies that keep their products compliant across regions. The ability to speed up the submission process while maintaining compliance will be a highly valued skill set in the coming years.
Growing Demand for Safe and Effective Products
There is a growing consumer and patient demand for safe, effective and high-quality products, from medication and medical devices to food. With more public awareness of product safety, transparency and efficacy, companies need to go beyond demonstrating that their products work. They must prove their products are also manufactured and monitored to the highest standards.
Quality assurance specialists help build this trust, giving patients peace of mind. As such, we will see more demand for these jobs in the future.
Rise of Digital Quality Management Systems
Digital quality management systems are taking over, changing how quality and regulatory teams operate. Professionals who are comfortable with electronic systems, analytics and continuous improvement strategies can do especially well in terms of future growth.
There will also be more opportunities for specialization, such as in software quality, post-market surveillance or global submissions.
Tips for QA and RA Job Seekers
Looking ahead, the career outlook for quality assurance and regulatory affairs jobs is more than about security — it’s about meaningful growth and the chance to shape the future of health and science.
As organizations invest in new technologies and expand into global markets, professionals in these fields will find themselves at the center of cross-functional teams, collaborating with R&D, clinical, manufacturing and commercial partners. This means strong communication and a willingness to adapt and learn are just as important as technical expertise.
For those entering the field, there are clear pathways to advance, from specialist roles to management and strategic leadership. Certifications like the Regulatory Affairs Certification or credentials from the American Society for Quality can further boost career prospects.
Why should someone consider a Quality and Regulatory Affairs career at Danaher?
“It is a fast-paced, dynamic work environment with a strong sense of teamwork and accountability.”
Senior Manager Product Compliance Engineering, Beckman Coulter Diagnostics
Advancing the Future of Human Health at Danaher
At Danaher, we believe that every breakthrough has the potential to change lives. Our mission is to accelerate the power of science and technology to improve human health, and our teams are united by a shared commitment to making a real-world impact. A career in quality assurance or regulatory affairs at Danaher means being at the heart of this mission.
Shaping the Future of Health
Our QA and RA professionals are trusted partners in every stage of the product life cycle — from research and development to manufacturing, commercialization and post-market support.
Across our global operating companies, we design, manufacture and sustain the tools, instruments and solutions that drive progress in life sciences, diagnostics and biotechnology.
“You’ll work in a dynamic, innovation-driven environment that values continuous improvement, ethical integrity, and cross-functional collaboration. With access to the Danaher Business System and a global network of operating companies, you’ll have room to grow, develop your expertise, and explore diverse career paths within the organization.”
Talent Advisor, Danaher
Competitive Benefits
We know that our people are our greatest strength. That’s why we offer competitive benefits that support the physical, financial and emotional well-being of our team.
Through the Danaher Business System (DBS), we provide world-class tools and training for continuous improvement and career development. Whether professionals want to deepen their expertise or take on new challenges, they can find opportunities to grow and make a difference.
Inclusive Culture
Inclusion and belonging are core to our culture. We value the unique perspectives and experiences that each associate brings, and foster an environment where everyone can thrive. Collaboration is at the heart of how we work, including across teams, disciplines and geographies. Together, we can solve the world’s most complex health challenges.
Passionate Global Team
When professionals join Danaher, they join a global team passionate about advancing human health. The work of QA and RA professionals will help bring life-changing innovations to market, support the highest standards of patient care and build trust with customers and communities worldwide.
To make a meaningful impact and be part of something bigger, we invite professionals to explore a future with us.
“We make a difference in what we do and how we do it to protect our customers and ultimately the patients that rely on our products and services.”
Senior Manager Product Compliance Engineering, Beckman Coulter Diagnostics
Explore Quality and Regulatory Affairs Jobs at Danaher
Ready to take the next step in your career? At Danaher, you’ll find quality assurance and regulatory affairs jobs that let you make a real difference, every day. Join a team where your expertise is valued, your growth is supported, and your work directly impacts the future of human health. Whether you’re an experienced professional or just starting out, there’s a place for you at Danaher.
Explore the positions available and discover how you can contribute to a mission-driven organization at the forefront of science and technology. Apply today and help us shape the future of health and science, one innovation at a time.
