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 lead collaborates cross‑functionally with Product Development, Quality, Manufacturing, Marketing, Legal, and Compliance teams to ensure regulatory alignment and market readiness. This role leads the development and execution of global regulatory strategies, manages submissions and regulatory changes, and supports product launches across international markets.

The regulatory expertise is critical in maintaining compliance throughout the product lifecycle and shaping the regulatory roadmap for emerging technologies and markets.

This is a hybrid role (2 days at home per week and 3 days in the office per week) in Beverly MA
. Willingness to travel internationally (~10%) is required.

• 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 material 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.

• 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 a related field
• Master’s degree
• Regulatory Affairs Certification (RAC) or equivalent professional certification
• Regulatory knowledge on US:…