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Regulatory compliance specialist skills for your resume and career

Updated January 8, 2025
7 min read
Regulatory compliance specialist example skills
Below we've compiled a list of the most critical regulatory compliance specialist skills. We ranked the top skills for regulatory compliance specialists based on the percentage of resumes they appeared on. For example, 10.0% of regulatory compliance specialist resumes contained risk assessments as a skill. Continue reading to find out what skills a regulatory compliance specialist needs to be successful in the workplace.

15 regulatory compliance specialist skills for your resume and career

1. Risk Assessments

The process of analyzing and identifying the acts or events that have the potential to negatively affect an individual, asset, or business is called risk assessment. Risk assessments are important because they form an integral part of an organization as well as occupational safety plans

Here's how regulatory compliance specialists use risk assessments:
  • Mitigated risk by preparing regulatory risk assessments of audit findings.
  • Investigate accidental discharges into the sanitary sewer system and storm drain; risk assessments; remediation; RCRA; SARA.

2. Regulatory Compliance

Here's how regulatory compliance specialists use regulatory compliance:
  • Led and coordinated all Regulatory Compliance security protocols and achieved 100% deficient-free findings on multiple sites with Maritime Security Regulations.
  • Developed and maintained relationships with other regulatory compliance personnel representing the carriers and clients with whom the company had business interactions.

3. Regulatory Agencies

A regulatory agency is a Public Benefit Corporation (PBC) that is responsible for supervising certain human activities and controlling them to some extent. They are set up in some areas such as hospitals, law firms, and governmental setup to regulate safety standards. They prevent undue and unjust abuse of power in these setups.

Here's how regulatory compliance specialists use regulatory agencies:
  • Conducted regulatory reviews for state and federal regulatory agencies, and prepared audit selections for internal and external compliance examinations.
  • Investigate, document, and resolve complex compliance issues from a legislative/regulatory standpoint, judiciously engaging regulatory agencies.

4. HIPAA

Here's how regulatory compliance specialists use hipaa:
  • Ensured compliance with HIPAA and HITECH Act requirements.
  • Established HIPAA curriculums and conducted classroom training to Business Associates, Privacy and Security officials.

5. Government Regulations

Government regulations refer to the guidelines that the governing body sets for all types of activities. Most of them are in a universal language like English so that a common man can easily understand them.

Here's how regulatory compliance specialists use government regulations:
  • Implemented training program to comply with OSHA, EPA and DOT government regulations.
  • Maintain freight records in compliance with government regulations.

6. Regulatory Submissions

Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during product development.

Here's how regulatory compliance specialists use regulatory submissions:
  • Support Regulatory Affairs department during preparation of domestic/international regulatory submissions.
  • Reviewed the Quality Overall Summary and Product Development Reports in preparation for regulatory submissions and responded to FDA observations as appropriate.

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7. ISO

Here's how regulatory compliance specialists use iso:
  • Planned and conducted internal quality audits to QSR, ISO 13845:2003, CMDCAS and MDD requirements ensuring internal audits were conducted.
  • Establish and maintain procedures pertaining to compliance with the ISO 9901 and 14001 standards; participate in the ISO audit process

8. External Audits

Here's how regulatory compliance specialists use external audits:
  • Assist the Senior Quality Auditor in designing audit plans for internal and external audits and routing deviations as required.
  • Assist during internal and external audits, including regulatory inspections pertaining to complaints and ADEs.

9. Strong Analytical

Here's how regulatory compliance specialists use strong analytical:
  • Position required strong analytical, research and organizational skills.
  • Position required a high level of accuracy and strong analytical skills.

10. Encryption

Here's how regulatory compliance specialists use encryption:
  • Assign Export Control Numbers to parts which contain encryption technology in order to stay in compliance with export regulations.

11. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how regulatory compliance specialists use fda:
  • Assisted with writing deviations and documenting customer concerns/complaints based on established customer specifications and FDA regulations.
  • Assured compliance to FDA and international regulatory requirements.

12. Internal Audit

Internal audit is an evaluation process that ensures that a company's risk management, governing body, and other internal processes are running effectively. People who perform internal audits must be highly qualified, have experience, and knowledge to work accordingly with the international standards and the code of ethics.

Here's how regulatory compliance specialists use internal audit:
  • Conduct internal audits to ensure compliance within our organization.
  • Identified corrective actions as required by process deviations, procedure deviations, complaints, regulatory audits, customer and internal audits.

13. Management System

A management system is a set of policies, processes, and procedures taken by an organization or a business to ensure it can fulfill its tasks and achieve its objectives. A management system makes sure that the company excels financially and improves the user experience. The management system also takes care of the worker's and employees' needs and manages their workload and oversees their performance. Apart from interior matters of the company, a management system also deals with exterior matters like legislations, tax matters, and law issues.

Here's how regulatory compliance specialists use management system:
  • Perform data entry of regulatory documents as well as maintenance of Investigator Information in Clinical Trial Management system.
  • Key contributor in development and implementation of Product Information Management System that improved operational efficiency.

14. Regulatory Risk

Here's how regulatory compliance specialists use regulatory risk:
  • Lead on identifying regulatory risk areas and working with business owners to properly identify plan of actions and support implantation.
  • Managed Regulatory Risk consulting engagements that focused on consumer compliance and risk management.

15. QA

QA, or Quality Assurance is a procedure that entails all of the steps taken to avoid any errors in the manufacturing process or in the production of the goods that a company produces. It can also include ensuring the consistency of the services rendered. Quality assurance ensures that the quality of the service delivered to consumers meets or exceeds the promised expectations. This greatly aids in the prevention of any complications that might arise after the goods or services have been distributed. It makes sure that customers are satisfied.

Here's how regulatory compliance specialists use qa:
  • Conducted audits in support of the Clinical QA Electronic Data Integrity group (computer validation audits).
  • Provide Regulatory and QA support on multiple new development project teams.
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List of regulatory compliance specialist skills to add to your resume

Regulatory compliance specialist skills

The most important skills for a regulatory compliance specialist resume and required skills for a regulatory compliance specialist to have include:

  • Risk Assessments
  • Regulatory Compliance
  • Regulatory Agencies
  • HIPAA
  • Government Regulations
  • Regulatory Submissions
  • ISO
  • External Audits
  • Strong Analytical
  • Encryption
  • FDA
  • Internal Audit
  • Management System
  • Regulatory Risk
  • QA
  • GCP
  • QMS
  • Data Analysis
  • Health Insurance
  • Product Development
  • Regulatory Bodies
  • Compliance Issues
  • Regulatory Issues
  • EPA
  • Internal Controls
  • GMP
  • OSHA
  • Federal Regulations
  • Anti-Money Laundering
  • MDR
  • Audit Findings
  • SharePoint
  • CAPA
  • Corrective Action
  • Hazardous Materials
  • State Regulations
  • Regulatory Changes
  • Medicaid
  • Data Entry
  • CMS
  • State Agencies
  • Medical Devices
  • QC
  • R
  • Government Agencies
  • Regulatory Guidance
  • Quality System
  • USDA

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

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