Regulatory Affairs & Compliance Lead

About the role

The Regulatory Affairs & Compliance Lead at Sensitech ensures regulatory alignment and market readiness for Sensitech’s comprehensive product portfolio, which includes hardware, software, sensors, and data services. This role is pivotal in enabling rapid market access and sustaining Sensitech’s commitment to innovation and quality.

Key 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.

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