Regulatory Affairs & Compliance Lead

About this role As the Regulatory Affairs & Compliance Lead at Sensitech, you will be the regulatory subject‑matter expert for our comprehensive product portfolio, which includes hardware, software, sensors, and data services. In this strategic individual contributor role, the Regulatory Affairs & Compliance Lead collaborates cross‑functionally with Product Development, Quality, Manufacturing, Marketing, Legal, and Compliance teams to ensure regulatory alignment and market readiness. The Regulatory Affairs & Compliance Lead leads the development and execution of global regulatory strategies, manages submissions and regulatory changes, and supports product launches across international markets. The Regulatory Affairs & Compliance Lead expertise is critical in maintaining compliance throughout the product lifecycle and in shaping the regulatory roadmap for emerging technologies and markets. This role is pivotal in enabling rapid market access and sustaining Sensitech’s commitment to innovation and quality. Key Responsibilities Regulatory Strategy & Market Access 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. Global Regulatory Intelligence & Monitoring 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. Product Development & Cross‑Functional Collaboration 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. Regulatory Submissions & Certifications 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. Vendor & Test House Coordination 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. Product Lifecycle & Compliance Oversight 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. Documentation & Labeling Review, approve, and maintain product labeling, technical documentation, and promotional/marketing materials for regulatory compliance. Process Development & Training 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. Stakeholder Engagement Liaise with external regulatory agencies, notified bodies, certification labs, and industry associations. Respond to regulatory and compliance‑related inquiries from customers and internal teams. Qualifications 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 Preferred Qualifications 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, ISO 14971, ISO 27001, IEC 62304, IEC 60601 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 Additional Information Hybrid role (2 days at home per week and 3 days in the office per week) in Beverly, MA. Willingness to travel internationally (approx. 10%). Must have unrestricted authorization to work in the USA. No visa sponsoring available. Pay Range The annual salary for this position is between $96,000.00 - $192,000.00 annually. Factors which may affect pay within this range include, but are not limited to, skills, education, experience, and other unique qualifications of the successful candidate. 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 EEO Statement and Accommodations Process 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 section503 of Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act. If you require a reasonable accommodation to complete the application process, participate in an interview, or otherwise engage in the hiring process, please contact us at View email address on click.appcast.io. We will make every effort to meet your needs in accordance with applicable laws. #J-18808-Ljbffr