Regulatory Affairs & Compliance Lead

About Carrier:

Carrier global leader in intelligent climate and energy solutions is committed to creating innovations that bring comfort safety and sustainability to life. Through cutting-edge advancementsin climate solutions such astemperature control air quality and transportation we improve lives empower critical industries and ensure the safe transport of food life-saving medicines and more. Since inventing modern air conditioning in 1902 we lead with purpose: enhancing the lives we live and the world we share. We continue to lead because of our world-class inclusive workforce that puts the customer at the center of everything we do. For more information visit follow Carrier on social media at @Carrier.

Sensitech Inc. a Carrier company under the Climate Solutions Transportation (CST) segment is a global leader in supply chain visibility solutions. Sensitech helps ensure the quality and integrity of temperature-sensitive products across the pharmaceutical food and industrial sectors. As part of Carrier Global Corporation Sensitech is committed to innovation sustainability and global impact.

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 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 Sensitechs commitment to innovation and quality.

This is a hybrid role in Beverly MA. Willingness to travel internationally (approx. 10%).

We value our people and offer an extensive benefits package with financial rewards including health insurance retirement savings plan and also lifestyle support with flexible working and parental leave. Plus well support your growth with paid-for external training programs and courses.

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

• Bachelors 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

• Bachelors degree in engineering life sciences regulatory affairs or a related field.

• Masters 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.

RSRCAR

#LI-hybrid

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 to15 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; military leave;purchasedvacation

• Disability: Short-term and long-term disability

• Life Insurance and Accidental Death and Dismemberment

• Tax-Advantaged Accounts: Health Savings Account; Healthcare Spending Account; Dependent Care Spending Account

• Tuition Assistance

To learn more about our benefits offering please click here: Work With Us Carrier Corporate 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.

This position is entitled to short-term cash incentives subject to plan requirements.

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.

Pay Range:

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.

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