Quality and Regulatory Affairs Specialist Job Description [Updated for 2025]

In today’s regulatory landscape, the importance of Quality and Regulatory Affairs Specialists is more pronounced than ever.

As industries evolve, so do their governing standards. With every transition, the demand for capable professionals who can navigate, adapt, and enforce these regulatory frameworks only grows stronger.

But let’s delve deeper: What’s truly expected from a Quality and Regulatory Affairs Specialist?

Whether you are:

• A job seeker trying to understand the core responsibilities of this role,
• A hiring manager outlining the perfect candidate,
• Or simply curious about the intricacies of quality and regulatory affairs,

You’ve come to the right place.

Today, we reveal a customizable Quality and Regulatory Affairs Specialist job description template, designed for effortless posting on job boards or career sites.

Let’s get started.

Quality and Regulatory Affairs Specialist Duties and Responsibilities

Quality and Regulatory Affairs Specialists work to ensure that their company’s products meet all necessary quality standards and comply with relevant regulations.

Their duties typically involve a mix of quality control, compliance work, and regulatory affairs.

The duties and responsibilities of a Quality and Regulatory Affairs Specialist include:

• Reviewing company policies and procedures to ensure they meet regulatory standards
• Collaborating with product development teams to ensure regulatory compliance is considered during the design process
• Preparing and submitting documentation to regulatory agencies
• Keeping up-to-date with changes in regulatory legislation and guidelines
• Monitoring and setting standards for quality control
• Investigating and setting standards for safety and health
• Assessing product, compliance, or operational risks and developing risk management strategies
• Conducting internal audits to measure and assure adherence to established QA standards for software development, application integration, and information system performance
• Training staff and team members about regulatory and compliance issues
• Maintaining and organizing necessary documentation
• Addressing non-compliance issues

 

Quality and Regulatory Affairs Specialist Job Description Template

Job Brief

We are seeking a detail-oriented Quality and Regulatory Affairs Specialist to help ensure our products meet the necessary regulations and standards.

The Quality and Regulatory Affairs Specialist will work closely with various departments to ensure compliance with local, national, and international regulatory requirements.

The ideal candidate should have a strong understanding of regulatory procedures and standards, such as ISO 9001, FDA regulations, or European Medical Device Regulations (MDR).

In this role, you will manage product submissions, maintain regulatory documentation, and coordinate internal and external audits.

 

Responsibilities

• Develop and implement strategies and plans for regulatory approval to introduce new and modified products to market
• Prepare and maintain regulatory documentation in accordance with procedures and regulations
• Coordinate and conduct internal and external audits to ensure compliance with regulatory requirements
• Ensure that the quality management system is established, implemented, and maintained in compliance with ISO 9001
• Monitor regulatory developments, including changes in laws, regulations, or standards, and communicate relevant changes to the appropriate teams
• Assist in the development and review of product labeling, promotional materials, and product claims to ensure regulatory compliance

 

Qualifications

• Proven work experience in Quality Assurance or Regulatory Affairs
• Knowledge of relevant regulations and standards (e.g., ISO 9001, FDA, MDR)
• Excellent organizational skills with the ability to manage multiple projects simultaneously
• Strong written and verbal communication skills
• Attention to detail and problem-solving skills
• Ability to interpret and apply regulatory standards
• Bachelor’s degree in a related field, such as science, engineering, or law

 

Benefits

• 401(k)
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Continuous professional development opportunities

 

Additional Information

• Job Title: Quality and Regulatory Affairs Specialist
• Work Environment: This position is primarily office-based with some flexibility for remote work. Travel may be required for audits or industry events.
• Reporting Structure: Reports to the Director of Regulatory Affairs or Quality Assurance Manager.
• Salary: Salary is commensurate with experience and qualifications, in line with market rates.
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
• Application Instructions: Please submit your resume and a cover letter detailing your experience and qualifications to [email address or application portal].

 

What Does a Quality and Regulatory Affairs Specialist Do?

Quality and Regulatory Affairs Specialists typically work in industries such as pharmaceuticals, medical devices, biotechnology, food and beverage, or any industry that requires compliance with regulatory standards.

Their main role is to ensure that their organization complies with all the regulations and laws pertaining to their business.

They work closely with other departments such as research and development, production, and marketing, to provide regulatory advice and guidance.

Quality and Regulatory Affairs Specialists are responsible for monitoring and keeping up to date with changes in regulatory legislation and guidelines.

They review and approve labeling, advertising, and promotional materials to ensure that they are in compliance with regulatory requirements.

These specialists also prepare regulatory submission documents and coordinate with regulatory agencies during the product information submission process.

They may also be involved in implementing and managing quality management systems to meet industry-specific regulations.

Quality and Regulatory Affairs Specialists conduct internal audits to identify any non-compliance areas and implement corrective actions.

They also coordinate external audits conducted by regulatory agencies.

In the event of a product issue, they are involved in the investigation and reporting of product complaints and adverse events.

They may also contribute to the development and implementation of recall procedures.

In summary, their main goal is to ensure that their organization operates in a compliant manner while meeting all quality standards.

 

Quality and Regulatory Affairs Specialist Qualifications and Skills

A Quality and Regulatory Affairs Specialist should possess a range of technical skills, soft skills, and industry knowledge to ensure compliance with the regulatory standards of products, processes, and systems, including:

• Strong knowledge of regulatory and quality management standards and regulations in order to effectively oversee and manage quality assurance procedures.
• Superb analytical and problem-solving skills to identify and address issues pertaining to quality assurance and regulatory compliance.
• Excellent communication skills to interact with various stakeholders, draft reports, and communicate findings and recommendations clearly and effectively.
• High level of attention to detail to ensure all procedures, products, and systems adhere to strict regulatory standards and requirements.
• Proficient in document management systems and processes necessary for maintaining accurate regulatory and quality assurance records.
• Strong interpersonal skills to work effectively with team members, management, and external regulatory bodies.
• Ability to interpret and apply laws, regulations, policies and procedures applicable to the organization’s operational activities.
• Project management skills to handle multiple projects simultaneously while meeting deadlines and maintaining high-quality standards.

 

Quality and Regulatory Affairs Specialist Experience Requirements

For an entry-level position as a Quality and Regulatory Affairs Specialist, companies typically require a minimum of 1 to 3 years of relevant experience.

This can be obtained through internships, part-time roles, or even project work during studies.

Roles such as Quality Assurance Intern, Quality Control Assistant, or Regulatory Affairs Coordinator can provide invaluable experience and knowledge.

Candidates with 3 to 5 years of experience may have worked in full-time Quality Assurance or Regulatory Affairs roles and have a solid understanding of regulatory requirements and quality standards in their respective industry.

They might have been involved in the development and implementation of quality systems and regulatory strategies, as well as in compliance audits.

Professionals with over 5 years of experience in quality and regulatory affairs are expected to have advanced knowledge of the regulatory environment and quality management systems.

They often have a track record in regulatory submissions and dealings with regulatory bodies.

They may also have experience in leading teams or managing projects, qualifying them for senior or managerial positions.

Regardless of the level, these specialists should have experience in interpreting and applying regulatory guidelines, staying updated with changes in regulatory legislation, and ensuring compliance with all necessary regulations.

 

Quality and Regulatory Affairs Specialist Education and Training Requirements

Quality and Regulatory Affairs Specialists typically need a bachelor’s degree in a field related to the industry they wish to work in, such as chemistry, biology, or engineering for pharmaceutical and medical devices industries.

In-depth knowledge and understanding of local, national, and international regulations and laws is critical in this role.

Therefore, many specialists continue their education with advanced degrees or certificates in quality assurance or regulatory affairs.

Due to the highly specialized nature of the job, some employers may require a master’s degree in regulatory affairs, law, or business administration.

Others may prefer candidates with relevant work experience in quality assurance or regulatory affairs.

Many employers prefer candidates who have earned certifications from recognized regulatory professional organizations.

These certifications validate the specialist’s understanding of regulatory and quality standards and guidelines.

Continuing education is a key aspect of this role as regulations and laws often change.

Therefore, a commitment to ongoing learning is crucial for a Quality and Regulatory Affairs Specialist.

They may also need training in specific software applications or systems that are commonly used in the field, like electronic document management systems and quality management systems.

Lastly, strong communication and analytical skills are necessary to interpret complex regulations and ensure that products meet these requirements.

 

Quality and Regulatory Affairs Specialist Salary Expectations

The average salary for a Quality and Regulatory Affairs Specialist is around $71,674 (USD) per year.

However, this amount may fluctuate based on factors such as the individual’s level of experience, the location of the job, and the size and type of the employing organization.

 

Quality and Regulatory Affairs Specialist Job Description FAQs

What are the key skills required for a Quality and Regulatory Affairs Specialist?

Quality and Regulatory Affairs Specialists must possess strong analytical skills, attention to detail, and knowledge of regulatory standards.

They must also have excellent communication skills to liaise effectively between all sectors of the company and regulatory authorities.

In addition, they need to have good problem-solving skills and the ability to manage multiple projects at once.

 

Do Quality and Regulatory Affairs Specialists need a degree?

Yes, typically, a Quality and Regulatory Affairs Specialist requires a bachelor’s degree in a scientific field.

For more senior positions, a master’s degree or further specialization in quality assurance and regulatory affairs may be required.

Additionally, experience in a related field is often a prerequisite for this role.

 

What should you look for in a Quality and Regulatory Affairs Specialist resume?

Look for a background in a scientific field, with education and experience in quality assurance and regulatory affairs.

Check for knowledge of relevant regulations and guidelines, such as FDA or EU regulations, depending on your location.

Also, look for key skills such as attention to detail, analytical skills, and excellent written and verbal communication skills.

Experience with preparing regulatory submission documents and conducting internal audits would also be advantageous.

 

What qualities make a good Quality and Regulatory Affairs Specialist?

A good Quality and Regulatory Affairs Specialist is meticulous and detail-oriented, ensuring all regulations are met and documentation is accurate.

They are also adaptable, able to keep up with changing regulations and requirements.

Strong communication skills are crucial, as they will need to liaise with various internal departments and external regulatory bodies.

They should also be highly organized to manage multiple tasks and projects simultaneously.

 

How important is the role of a Quality and Regulatory Affairs Specialist in a company?

Quality and Regulatory Affairs Specialists play a crucial role in ensuring that products meet necessary quality standards and comply with local, national, and international regulations.

Their work is vital for maintaining a company’s reputation, customer trust, and avoiding penalties or legal consequences due to non-compliance.

They also contribute to the efficiency and profitability of the business by identifying ways to improve quality and compliance processes.

 

Conclusion

There you have it.

Today, we’ve delved into the fascinating world of a Quality and Regulatory Affairs Specialist.

And what did we discover?

It’s not just about ensuring compliance.

It’s about safeguarding the quality and integrity of products, one regulatory guideline at a time.

Armed with our comprehensive Quality and Regulatory Affairs Specialist job description template and real-life examples, you’re ready to take the next step.

But why stop there?

Go further with our job description generator. It’s your stepping stone to meticulously-crafted listings or fine-tuning your resume to brilliance.

Remember:

Every regulatory guideline is a vital piece in the puzzle of product integrity.

Let’s ensure that quality. Together.

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