Regulatory Affairs Specialist

Clinician's Choice; Lompoc (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

A healthcare compliance company is seeking a candidate responsible for acquiring, maintaining, and auditing licensing and product registration. The ideal candidate will have 2 to 4 years of experience in regulatory compliance, guiding operations in adherence to Federal, State, and Local regulations. A Bachelor's Degree in a related field is preferred, along with strong analytical, communication, and problem-solving skills. This role offers the opportunity to participate in special projects and ensure ongoing compliance with essential regulations.

Qualifications

• 2 to 4 years of related professional experience required.
• Typically hold 1 or more industry certifications.

Responsibilities

• Acquire and maintain company licensing and product registration.
• Research legislation to ensure ongoing compliance.
• Guide operations on compliance issues.
• Provide support during inspections and audits.

Skills

Research and analysis of laws and regulations

Implementation of compliance systems

Monitoring of DOT and OSHA regulations

Communication and interpersonal skills

Conflict resolution

Education

Bachelor's Degree in a related discipline

Job description

This position is responsible to acquire/maintain/audit company licensing and product registration. Research and analyze applicable legislation and Federal, State, and Local regulations to ensure the company’s ongoing compliance. Guide Operations and other areas of the company on compliance issues related to the area of expertise.

• Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State, and local requirements
• Implement systems and processes needed to ensure compliance with the receipt, storage, and distribution of regulated products, as well as tracking the distribution of prescription drugs and medical devices
• Monitor compliance with DOT requirements for the classification, storage, and distribution of Hazardous Materials, as well as the activities to comply with environmental laws
• Coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations
• Provide support during inspections and audits, and formulate the appropriate response and corrective actions
• Guide the company and subsidiaries to perform actions to maintain regulatory compliance for various facilities
• Provide cross-functional support to the Corporate Brand Development Group and other Business Units researching issues pertaining to regulatory matters. Secure and maintain proper company licensure and product registration as needed
• Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures.
• Participate in special projects and perform other duties as required.

WORK EXPERIENCE

Typically 2 to 4 years of related professional experience.

PREFERRED EDUCATION

Bachelor's Degree or global equivalent in a related discipline. Typically hold 1 or more industry certifications.

GENERAL SKILLS & COMPETENCIES

• Professional skills with an understanding of industry practices, company policies, and procedures.
• Developing proficiency with tools, systems, and procedures.
• Good planning/ organizational skills and techniques.
• Developing problem-solving skills.
• Good writing and communication skills.
• Excellent conflict resolution skills.
• Excellent interpersonal skills.Exercise judgment within defined procedures and practices to determine appropriate action.
• Direction from the manager/director is needed on some issues.

SPECIFIC KNOWLEDGE & SKILLS

• Thorough understanding of regulations applicable to HS operations