Regulatory Affairs & Compliance Lead

Regulatory Affairs & Compliance Lead

Job :
- Location:

Beverly, MA (Hybrid, travel ~10%)

About the Company

Carrier, a global leader in intelligent climate and energy solutions, has a subsidiary Sensitech that provides supply‑chain visibility solutions for temperature‑sensitive products across pharmaceutical, food, and industrial sectors.

About the Role

The Regulatory Affairs & Compliance Lead at Sensitech serves as the regulatory subject‑matter expert for hardware, software, sensors, and data services. This strategic individual contributor collaborates cross‑functionally with Product Development, Quality, Manufacturing, Marketing, Legal, and Compliance to ensure regulatory alignment and market readiness.

• 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 (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.
• 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.
• Manage regulatory submissions, filings, registrations, certificates, and renewals across global markets; coordinate WHO/PQS, country‑specific certifications, battery and airline certifications, REACH/RoHS/PFAS compliance.
• Liaise with third‑party vendors, test houses, and external consultants; support engineering teams in testing and certification processes.
• Evaluate regulatory impact of product and process changes; direct regulatory change notifications or approvals as required.
• Maintain post‑market surveillance, field actions, complaint handling, and regulatory reporting; ensure readiness for audits and inspections.
• Review, approve, and maintain product labeling, technical documentation, and promotional/marketing materials.
• Develop and maintain SOPs, work instructions, and best practices for regulatory affairs processes; provide training and guidance to internal stakeholders.
• Liaise with external regulatory agencies, notified bodies, certification labs, and industry associations; respond to regulatory inquiries and customer requests.

• 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.

• Bachelor’s degree in engineering, life sciences, regulatory affairs, or related field.
• Master’s degree.
• Regulatory Affairs Certification (RAC) or equivalent.
• Regulatory knowledge of FDA/FCC, EU MDR and related directives, Canada Health Canada, NMPA, wireless/telecom certifications, supply‑chain sensor regulations.
• Experience with ISO 13485, ISO 14971, ISO 27001, IEC 62304, IEC 60601, and related standards.
• Lead regulatory interfaces with authorities or notified bodies; prepared and led filings, registrations, certifications across multiple countries.
• Experience supporting or leading regulatory audits and inspections.
• Exposure to cold‑chain monitoring, sensor/IoT, connected devices industries.
• Strong interpersonal skills for cross‑departmental and external partner collaboration.
• Ability to monitor regulatory changes and adjust strategies accordingly.
• Comfortable working in a fast‑paced, evolving environment.

• Must have unrestricted authorization to work in the USA; no visa sponsorship available.

• Health, Dental & Vision insurance; wellness incentives.
• Retirement savings plan.
• Paid time off: vacation, sick, personal, holidays, parental leave, family & medical leave, bereavement, jury duty, military leave.
• Disability and life insurance benefits.
• Health Savings Account, Healthcare Spending Account, Dependent Care Spending Account.
• Tuition assistance.

Pay Range
: $118,000 – $165,000

EEO Statement

Carrier is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. Carrier provides affirmative action in employment for qualified individuals with a disability and protected veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act.