Top 15 Regulatory Compliance Specialist Skills (2024)

15 regulatory compliance specialist skills for your resume and career

1. Risk Assessments

A risk assessment is a process that helps identify and evaluate potential risks. Regulatory compliance specialists use risk assessments to determine the likelihood and potential impact of different risks, such as audit findings or accidental discharges into the sanitary sewer system. They also conduct workplace exposure and risk assessments to recommend prevention methods and exposure controls. Additionally, they perform risk assessments to evaluate the adequacy of technical and logical security controls and business continuity plans for financial institutions.

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

Regulatory compliance is the act of adhering to laws and regulations that apply to a business. Regulatory compliance specialists use regulatory compliance to ensure that their company follows these regulations, for example, by coordinating all aspects of regulatory compliance, leading audits, and managing databases. They also use regulatory compliance to investigate processes, develop proposals, and provide reports.

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

Regulatory agencies are organizations responsible for enforcing laws and regulations related to a particular industry or activity. Regulatory compliance specialists use these agencies by conducting reviews, investigating violations, and responding to information requests. They work with regulatory agencies to ensure compliance with laws and regulations, negotiate requirements, and submit materials for review.

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

HIPAA stands for Health Insurance Portability and Accountability Act. Regulatory compliance specialists use HIPAA to ensure the privacy and security of patients' personal and medical information. They create HIPAA curriculums and conduct training sessions to educate business associates and officials about HIPAA requirements. They also analyze and summarize federal and state legislation to provide parameters for administrative business decisions, such as the HIPAA legislation.

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 rules and guidelines established by the government to protect the public and ensure fair business practices. Regulatory compliance specialists use these regulations to ensure that their company or organization is in compliance with federal and state laws. They interpret and apply regulations, analyze employment practices and procedures, and review freight records. They may also provide training programs to comply with OSHA, EPA, and DOT regulations.

Here's how regulatory compliance specialists use government regulations:

6. Regulatory Submissions

Regulatory submissions are the documents or information that companies must submit to regulatory agencies for approval of their products. Regulatory compliance specialists use regulatory submissions to support the Regulatory Affairs department during preparation, review changes to existing products, determine requirements, and prepare and provide content for post-market surveillance programs. They also audit the information filed in these submissions and prepare them for the FDA.

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

ISO stands for International Organization for Standardization. Regulatory compliance specialists use ISO in various ways. For instance, they conduct internal quality audits to ensure compliance with ISO requirements. They may also establish and maintain procedures to meet ISO standards and facilitate meetings to review and improve their processes according to ISO regulations.

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

External audits are evaluations conducted by a third party to assess a company's compliance with laws, regulations, and standards. Regulatory compliance specialists use external audits to ensure their company complies with these requirements. They help design audit plans, submit documentation packages for review, communicate requirements to teams, and coordinate audits. They also maintain company compliance records for accuracy and availability.

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

Strong analytical skills are the ability to analyze, interpret, and draw conclusions from data. Regulatory compliance specialists use these skills to ensure that their organization follows all relevant regulations. They need to be able to research and analyze legal documents, analyze data, and make informed decisions based on their findings. For example, one regulatory compliance specialist used their strong analytical skills to "Utilize strong analytical, writing, and editorial skills."

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

Encryption is the process of converting plain text into unreadable cipher text. Regulatory compliance specialists use encryption to assign export control numbers to parts that contain encryption technology. This helps them stay in compliance with export regulations.

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 federal agency responsible for ensuring the safety of food, drugs, and medical devices. Regulatory compliance specialists use the FDA's guidelines to ensure their company's products meet safety standards. They prepare filings for FDA oversight, conduct investigations, and submit reports to the FDA. They also ensure raw material compliance to FDA regulations, and provide support for FDA and Notified Body inspections.

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

An internal audit is a comprehensive examination of an organization's financial statements, systems, processes, and controls. Regulatory compliance specialists use internal audits to ensure compliance within their organization, track corrective actions, and identify potential areas of concern. They collaborate with internal auditors to review and maintain accuracy with state compliances, track CAPAs, and conduct regular internal audits to drive improvement efforts. They also supervise staff responsible for site internal audits, CAPA systems, and quality data analysis.

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 processes and tools used to manage and monitor a company's operations. Regulatory compliance specialists use management systems to track and maintain records of safety and environmental information. They also use these systems to manage data entry, maintain databases, and perform audits to ensure compliance with company policies and regulations. For example, a regulatory compliance specialist might use a management system to track and analyze environmental data to identify areas for improvement. They may also use these systems to monitor and report on safety incidents.

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

Regulatory risk is the risk that a company or organization will violate laws and regulations. Regulatory compliance specialists use regulatory risk by identifying potential risk areas and working with business owners to develop a plan of action. They also prepare regulatory risk assessments and recommend strategies for projects proposed by company management. For example, they may design and implement reorganizations that reduce regulatory risk and cost while increasing efficiency. Additionally, they may review marketing material to ensure it does not pose a 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 process that ensures a product or service meets a set of standards. Regulatory compliance specialists use QA by conducting audits, providing support for new development projects, and coordinating with various departments to gather documentation required for regulatory submissions. They also assist in QA documentation remediation projects and review process investigations to provide relevant information to QA management.

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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