What are the responsibilities and job description for the Regulatory Compliance Engineer position at Intellectt Inc?
Role: Product Compliance Engineer
Location: NY - Hybrid
Duration: 12 Months onsite
What You Will Be Doing
- Conduct comprehensive regulatory and compliance reviews of EClient/Wireless testing, test plans, and reports, ensuring proper test setups, input voltage, and immunity frequency standards.
- Perform wireless product testing for global market access and radio certifications.
- Manage the end-to-end radio certification process, including obtaining quotes, preparing DUTs, and attending test sessions at certification labs as needed.
- Prepare and submit required documentation for formal certifications and provide compliance-related support.
- Collaborate with cross-functional engineering teams (electrical, mechanical, and software) to resolve compliance issues.
- Maintain and update product radio technical files throughout the product lifecycle.
- Support product development teams in applying and understanding design standards and regulatory codes.
- Submit compliance reports to safety agencies and review third-party technical files and documentation for regulatory adherence.
What You Will Bring
- Bachelor’s degree in Electrical or Mechanical Engineering (or equivalent experience).
- Minimum 5 years of experience certifying wireless devices.
- Minimum 5 years of experience in Compliance Engineering, including working with Notified Bodies and regulatory standards.
- Strong knowledge of IEC 60601-1-2, CISPR 11, and IEC 61000 standards.
- Experience interpreting and applying regulatory radio standards, including FCC CFR 47 Part 15, ETSI standards (EN 300 328, EN 302 064, etc.), and others.
- Expertise in Global Market Access Wireless Certification across multiple countries, including Armenia, Bahrain, Brazil, China, Mexico, Saudi Arabia, Singapore, UAE, and more.
- Experience with Radiated Spurious Emissions and/or radiated EClient testing.
- Strong written and verbal communication skills.
- Self-motivated with a high-performance mindset.
- Preferred:
- Experience performing IEC 60601-X tests and test setups.
- Understanding of ISO 14971, FDA, and EU regulatory requirements.
- Familiarity with EClient systems.
