Regulatory Affairs & Compliance Lead

About the role

The Regulatory Affairs & Compliance Lead at Sensitech, a Carrier company, is responsible for developing and executing global regulatory strategies, managing submissions and regulatory changes, and supporting product launches across international markets. This role requires expertise in maintaining compliance throughout the product lifecycle and shaping the regulatory roadmap for emerging technologies and markets.

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).
• Manage regulatory submissions, filings, registrations, certificates, and renewals across global markets.
• Support product launch readiness and ensure regulatory compliance throughout development.
• Evaluate regulatory impact of product and process changes (e.g., design, manufacturing location, firmware/software updates, packaging, vendor changes).
• 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.

Requirements

• 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

Qualifications

• Bachelor’s degree in engineering, life sciences, regulatory affairs, or a related field
• Master’s degree preferred
• Regulatory Affairs Certification (RAC) or equivalent professional certification preferred
• 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 preferred
• Prepare and lead filings, registrations, or certifications across multiple countries preferred
• Support or lead regulatory audits and inspections preferred
• Exposure to supply-chain visibility, cold-chain monitoring, sensor/IoT, or connected devices industries preferred
• Interpersonal skills to work across departments and with external partners preferred
• Monitor regulatory changes and adjust strategies accordingly preferred
• Comfortable working in a fast-paced, evolving and transforming environment preferred

Benefits

• Health Care Benefits: Medical, Dental, Vision; Wellness incentives
• Retirement Benefits
• Time off and Leave: 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 leave; military leave; purchased vacation
• Disability: Short-term and long-term disability
• Life Insurance and Accidental Death and Dismemberment
• Tax-Advantaged Accounts: Health Savings Account; Health Care Spending Account; Dependent Care Spending Account
• Tuition Assistance