Carrier Climate Solutions Transportation · 1 month ago
Regulatory Affairs & Compliance Lead
Beverly, MA
Full-time
Hybrid
Mid, Senior Level
$120K/yr - $168K/yr
5+ years expCarrier Climate Solutions Transportation is a global leader in intelligent climate and energy solutions. The Regulatory Affairs & Compliance Lead will be responsible for developing and executing regulatory strategies, managing submissions, and ensuring compliance throughout the product lifecycle for a range of temperature-sensitive products.
Building Materials
No H1B
Responsibilities
Develop and implement regulatory strategies for new and modified products (hardware, sensors, IoT, software) to enable entry into target markets (US, EU, Asia, etc.)
Guide regulatory planning for emerging technologies and global expansion initiatives
Interpret and monitor global regulatory requirements (e.g., CE/MDR, FDA, ISO standards, environmental/transport regulations, wireless communications, data security)
Build and maintain regulatory intelligence; track changes in regulations, standards, and industry trends to inform business strategy
Serve as the regulatory lead on cross-functional product development teams
Engage early in design, risk management, verification/validation, labeling, packaging, marketing claims, and manufacturing changes
Support product launch readiness and ensure regulatory compliance throughout development
Manage regulatory submissions, filings, registrations, certificates, and renewals across global markets
Coordinate WHO/PQS certifications, country-specific certifications, and renewals
Oversee battery certifications, airline certifications, and REACH/RoHS/PFAS materials compliance
Generate and maintain Declarations of Conformity (DoC) as needed
Liaise with third-party vendors, test houses, and external consultants
Support engineering teams in testing and certification processes
Manage quote and purchase order processes for regulatory-related services
Evaluate regulatory impact of product and process changes (e.g., design, manufacturing location, firmware/software updates, packaging, vendor changes)
Direct regulatory change notifications or approvals as required
Maintain post-market surveillance activities, field actions, complaint handling, and regulatory reporting
Ensure readiness for regulatory audits and inspections
Review, approve, and maintain product labeling, technical documentation, and promotional/marketing materials for regulatory compliance
Develop and maintain SOPs, work instructions, and best practices for regulatory affairs processes
Provide training and guidance to internal stakeholders on regulatory requirements and procedures
Liaise with external regulatory agencies, notified bodies, certification labs, and industry associations
Respond to regulatory and compliance-related inquiries from customers and internal teams
Qualification
Required
Bachelor's degree
5 + years of progressive experience in regulatory affairs
2 years of experience with hardware, IoT, medical devices, or regulated electronics
2 years of experience managing regulatory aspects of design changes, firmware/software updates, packaging changes, and change control processes
Must have unrestricted authorization to work in the USA. No visa sponsoring available
Preferred
Bachelor's degree in engineering, life sciences, regulatory affairs, or a related field
Master's degree
Regulatory Affairs Certification (RAC) or equivalent professional certification
Regulatory Knowledge on US: FDA, FCC; EU: MDR, Radio Equipment Directive, Low Voltage, EMC; Canada, Asia: Health Canada, NMPA; Wireless/telecom certifications; Supply-chain sensor regulations
Experience with global standards such as: ISO 13485 (Quality management for medical devices); ISO 14971 (Risk management for medical devices); ISO 27001 (Information security management); IEC 62304 (Software lifecycle for medical devices); IEC 60601 (Medical electrical equipment safety)
Lead regulatory interface with regulatory authorities or notified bodies
Prepare and lead filings, registrations, or certifications across multiple countries
Support or lead regulatory audits and inspections
Exposure to supply-chain visibility, cold-chain monitoring, sensor/IoT, or connected devices industries
Regulatory strategy and submissions
Interpersonal skills to work across departments and with external partners
Monitor regulatory changes and adjusting strategies accordingly
Comfortable working in a fast-paced, evolving and transforming environment
Benefits
Health Care benefits: Medical, Dental, Vision; wellness incentives
Retirement benefits
Paid vacation days, up to 15 days
Paid sick days, up to 5 days
Paid personal leave, up to 5 days
Paid holidays, up to 13 days
Birth and adoption leave
Parental leave
Family and medical leave
Bereavement leave
Jury duty
Military leave
Purchased vacation
Short-term and long-term disability
Life Insurance and Accidental Death and Dismemberment
Health Savings Account
Healthcare Spending Account
Dependent Care Spending Account
Tuition Assistance
Company
Carrier Climate Solutions Transportation
The need has never been greater for safe and sustainable cold chain technologies.
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase