Regulatory Specialist Job Description Template

Are you a detail-oriented individual looking for a career in regulatory affairs? We are seeking a Regulatory Specialist to join our team. As a Regulatory Specialist, you will be responsible for ensuring compliance with regulations, developing and implementing policies and procedures, and conducting audits. If you have a strong understanding of regulations and enjoy working in a highly-regulated environment, apply today!

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Job Overview

The Regulatory Specialist is responsible for ensuring that a company is in compliance with all relevant laws, regulations, and guidelines related to their industry. This includes researching and interpreting regulations, developing policies and procedures, and monitoring compliance activities.


  • Conducting research and staying up-to-date on all relevant laws and regulations
  • Interpreting regulations and advising management on compliance requirements
  • Developing policies and procedures to ensure compliance with regulations
  • Implementing compliance training for employees
  • Collaborating with other departments to ensure compliance in all areas of the company
  • Conducting compliance audits and risk assessments
  • Preparing reports and documentation for regulatory agencies
  • Maintaining up-to-date knowledge and expertise in regulatory issues


  • Bachelor's degree in a related field
  • At least 3 years of experience in regulatory compliance
  • Strong knowledge of relevant laws and regulations
  • Excellent communication and interpersonal skills
  • Detail-oriented with strong analytical skills
  • Able to work independently and in a team environment
  • Proficient in Microsoft Office and other relevant software

Physical Requirements

The Regulatory Specialist may be required to sit or stand for extended periods of time and lift up to 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working Conditions

The Regulatory Specialist may work in an office environment, lab, or manufacturing facility. Some travel may be required to attend meetings or conferences. The job may require working overtime or on weekends to meet deadlines or address urgent issues.


If you are in need of a Regulatory Specialist to join your team, creating an effective job posting is essential to attracting the right candidates. In this article, we will discuss how to create a Regulatory Specialist job posting that effectively communicates your organization's needs and requirements.

Job Summary

The job summary of your posting should provide a brief overview of the position, highlighting the key responsibilities and qualifications required. This section should be concise and easy to read, providing candidates with a clear understanding of the primary purpose of the role.

  • Develop and implement regulatory plans, strategies, and submissions for the approval of medical devices, pharmaceuticals, or other related products.
  • Interpret and apply FDA, ISO, and other global regulatory requirements to ensure compliance.
  • Communicate with regulatory agencies and other stakeholders as necessary.
  • Provide guidance to cross-functional teams on regulatory issues impacting product development.
  • Responsibilities

    Use this section to elaborate on the key duties that the Regulatory Specialist will be responsible for. It is important to provide details about the daily tasks that the successful candidate will be expected to perform, ensuring that they have a clear understanding of the scope of the role.

  • Ensure compliance with all regulatory standards and requirements.
  • Prepare, submit and manage regulatory submissions, including pre-market notifications, product registrations, and annual reports.
  • Monitor changes in the regulatory environment and implement modifications to product development plans as necessary.
  • Develop and maintain product labeling and instructions for use in compliance with regulatory requirements.
  • Requirements

    In this section, outline the necessary qualifications and experience that candidates must possess in order to be considered for the position. This should include both technical and soft skills that are required for success in the role.

  • Bachelor's degree in a scientific discipline or related field.
  • Minimum of 3 years of experience in regulatory affairs for medical devices or pharmaceuticals.
  • Knowledge of FDA and ISO regulations and standards.
  • Excellent written and oral communication skills.
  • Benefits

    Communicating the benefits of employment is important for attracting successful candidates. Use this section to showcase the benefits of the role, such as flexible working hours, healthcare benefits or growth opportunities.

  • Competitive salary and benefits package.
  • Opportunities for professional development and growth.
  • Flexible working hours and work from home options.
  • Conclusion

    Creating an effective Regulatory Specialist job posting is crucial to attracting top talent to your organization. By following the tips outlined in this article, you can create a posting that effectively communicates the needs and requirements of the position, ensuring that only the most qualified candidates apply.

    What is a Regulatory Specialist?

    A Regulatory Specialist is responsible for ensuring that companies comply with applicable laws, regulations, and guidelines set by regulatory agencies. They must keep current with regulatory changes and ensure that the companies they work for are aware of any changes that may affect their business. They may also be responsible for analyzing data related to regulatory compliance and developing strategies to improve compliance efforts.

    What skills and qualifications should be included in a Regulatory Specialist job posting?

  • A Bachelor’s or Master’s degree in a relevant field, such as Regulatory Affairs or Life Sciences
  • Experience working in regulatory compliance for several years
  • Strong knowledge of regulations and guidelines set by regulatory agencies such as FDA, EMA, and ICH
  • Excellent analytical skills and ability to interpret complex data
  • Excellent written and verbal communication skills
  • Ability to work independently and as part of a team
  • Attention to detail and ability to multi-task and prioritize work effectively
  • What are some typical job duties of a Regulatory Specialist?

    The specific job duties of a Regulatory Specialist will vary depending on the company they work for and the industry they work in. However, some typical job duties may include:

  • Monitoring and interpreting regulatory changes that may impact the company
  • Working with other departments to ensure compliance with regulations and guidelines
  • Preparing and submitting regulatory documents to regulatory agencies
  • Conducting regulatory assessments and audits
  • Developing and implementing compliance strategies and policies
  • What are some common job titles for Regulatory Specialists?

    Some common job titles for Regulatory Specialists may include:

  • Regulatory Affairs Specialist
  • Senior Regulatory Affairs Specialist
  • Regulatory Affairs Manager
  • Regulatory Compliance Specialist
  • Regulatory Affairs Associate
  • What are some tips for creating a successful Regulatory Specialist job posting?

  • Be clear about the job duties and qualifications required for the role
  • Use specific language to describe the skills and experience required
  • Include information about the company culture and values to attract the right candidates
  • Be sure to include information about any benefits and career growth opportunities
  • Use a clear and concise job title that accurately reflects the position
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