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, manage submissions and regulatory changes, and support 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.
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 (approx. 10%).
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.
Basic 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 (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.
- 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
- Regulatory strategy and submissions
- Interpersonal skills to work across departments and with external partners
- Monitor regulatory changes and adjusting strategies accordingly.
- Comfortable working in a fast-paced, evolving and transforming environment.
Additional information
- 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.
Other Compensation
Thisposition is entitled to short-term cash incentives, subject to plan requirements.
Benefits
Employees are eligible for benefits, including:
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
To learn more about our benefits offering, please click here . The specific benefits available to any employee may vary depending on state and local laws and eligibility factors, such as date of hire and the applicability of collective bargaining agreements.
Application Deadline
Applications will be accepted for at least 3 days fromJobPosting Date: 20 May 2026
Use of AI
Technology-enabled tools may support parts of the recruitment process, with oversight by people.
