Environmental Compliance Specialist

Environmental Compliance Specialist

Job Description

The Environmental Compliance Specialist is responsible for supporting the development, implementation, maintenance, and continuous improvement of CAIRE’s Global Environmental Health and Safety Management System (GEHSMS) under the direction of the Global RA director. This position is responsible for ensuring compliance with global regulatory requirements applicable to CAIRE Inc. ‘s manufacturing operations, while also supporting environmental sustainability initiatives across all CAIRE locations.

The role provides technical and administrative support for regulatory compliance, environmental performance, risk reduction, and continuous improvement activities in alignment with corporate objectives and applicable international standards.

The position allocation is approximately:

-60% Regulatory Compliance Responsibilities

-40% Environmental Sustainability Responsibilities

Essential Duties and Responsibilities

Regulatory Compliance Responsibilities (60%)

-The position supports global regulatory compliance activities associated with country-specific product registrations, regulatory submissions, renewals, and maintenance requirements for the CAIRE Inc. product portfolio in accordance with applicable international regulatory frameworks and market-specific requirements.

These activities include, but are not limited to:

Coordination and support regulatory documentation and compliance activities required for global market access, including; Country registrations and product licensing, Regulatory submissions and renewals, Technical documentation support, Product compliance certifications, Regulatory record maintenance, Coordination with regulatory agencies, notified bodies, distributors, and in-country representatives as well as monitor and support compliance with evolving global medical device regulations and country-specific regulatory requirements impacting oxygen concentrator products and related manufacturing operations. Activities assigned by the Global RA Director.

Further; support compliance programs aligned with applicable regulatory and industry requirements, including:

-FDA regulations and expectations for medical device manufacturing environments

-ISO 13485 quality management system requirements

-OSHA occupational health and safety regulations

-NFPA standards related to oxygen systems and compressed gases

-Hazard Communication (HazCom) requirements

-Chemical safety and hazardous materials regulations

-Emergency preparedness and fire prevention requirements

Support compliance related to oxygen-enriched environments and oxygen system safety, including:

-Fire and explosion prevention measures

-Safe storage and handling of compressed gases and oxygen systems

-Ignition source control and chemical compatibility assessments

-Risk mitigation practices associated with oxygen concentrator manufacturing and servicing operations

Participate in regulatory inspections, internal audits, and compliance assessments to ensure adherence to corporate standards and applicable regulatory obligations.

Assist in the development, implementation, and maintenance of EHS procedures, work instructions, and compliance documentation supporting safe manufacturing and operational practices.

Support incident investigations, root cause analyses, corrective actions, and preventive action initiatives related to EHS compliance and operational safety.

Maintain Safety Data Sheet (SDS) management systems and chemical inventory tracking processes across all facilities.

Support employee training programs related to:

-Hazard Communication

-Chemical safety

-Oxygen safety awareness

-Emergency response procedures

-Personal protective equipment (PPE)

-Safe manufacturing and maintenance practices

Monitor regulatory developments and emerging requirements affecting oxygen concentrator manufacturing, medical devices, environmental compliance, and workplace safety regulations, and communicate impacts to relevant stakeholders.

Support contractor and vendor EHS compliance activities to ensure adherence to company policies and regulatory requirements.

Environmental Sustainability Responsibilities (40%)

Support the implementation and continuous improvement of environmental sustainability programs across global CAIRE facilities.

This relates to:

Coordination of environmental monitoring, reporting, and permit compliance activities, including:

-Air emissions monitoring and reporting

-Greenhouse Gas (GHG) emissions tracking

-Hazardous Air Pollutants (HAPs) monitoring

-Title V Air Permit compliance

-Stormwater management and reporting

-Wastewater compliance activities

-Hazardous and solid waste management programs

Support compliance with environmental regulations and reporting requirements, including:

-NESHAP requirements

-EPCRA reporting

-Tier II and Form R submissions

-SPCC requirements

-Environmental permit management

Develop and maintain environmental Key Performance Indicator (KPI) tracking systems and sustainability performance metrics.

Lead and support environmental continuous improvement initiatives focused on reducing CAIRE’s environmental footprint, including:

-Manufacturing waste reduction

-Recycling and waste diversion initiatives

-Energy efficiency improvements

-Facility weatherization projects

-Sustainable logistics optimization

-Renewable energy initiatives

Promote environmental stewardship and sustainability best practices throughout manufacturing and operational facilities.

Assist with environmental audits, inspections, corrective action plans, and continuous improvement activities.

Coordinate activities with external environmental consultants, monitoring agencies, laboratories, and regulatory authorities, as required.

Support environmental awareness and sustainability training initiatives for employees and site leadership teams.

Competencies

• Clerical skills.
• Organizing skills.
• Time management.
• Team Orientation.
• Problem solving.
• Attendance.
• Effective written and verbal communication skills.
• Attention to detail and commitment to compliance excellence.

Supervisory Responsibility

This position is an individual contributor role.

Work Environment

This job operates in a professional office environment and Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

•Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.

•Occasional lifting, up to 30 lbs., occasional heavier lifting with assisted devices.

•Occasional pushing, pulling, and handling of materials.

Travel

This position requires up to 25% travel. Some of the travel is international.

Required Education and Experience

•Minimum B.S. degree in Environmental Science, Environmental Engineering or related field aligned in Science or another engineering discipline

• Preferred - Professional certification in Environmental Management (REM or CHMM) or ability to obtain such certification.

• Strong knowledge of Environmental regulatory requirements, concepts, and best practices

• Good understanding of the Environmental issues, regulations, and technology that impacts the medical device industry.

Preferred Education and Experience

•Bachelor’s degree (environmental, industrial hygiene, safety, chemical, civil, or mechanical engineering.

•LSSGB Certification

•Environmental: Strong understanding of Federal and State environmental laws and regulations and Federal and State OSHA standards.

Working experience and strong knowledge of regulatory Environmental, Health and Safety practices and regulatory requirements (e.g. to air permits and compliance, wastewater discharge permit and compliance, wastewater treatment processes and management, groundwater withdrawal, waste management, sludge management, SPCC, storm water, emergency response/Hazwoper, SARA, ASTs and Boilers operation and compliance, soil and groundwater remediation machine guarding, lockout, electrical safety, chemical management, workers’ compensation management, risk assessment and management, ergonomic risk reduction, etc.) manufacturing/distribution environment.

Additional Eligibility Qualifications

Working knowledge of FDA regulated working environments. As well as ISO 13485 Quality management systems, as well as global medical device registration requirements/process.

Location

Office Ball ground (min. of 3 day onsite)

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.