We are seeking a Regulatory Compliance Lead responsible for ensuring global regulatory and standards compliance for medical X-ray generator systems, high-voltage power supplies, RF products, and related electronic assemblies. This role leads compliance activities related to product safety, EMC, radiation safety, environmental regulations, and quality management systems while supporting customer and market requirements.
YOU WILL BE ACCOUNTABLE FOR/TO:- Lead regulatory compliance activities for medical X-ray generators, high-voltage power supplies, RF products, and related electronic assemblies.
- Ensure compliance with FDA CDRH Radiation Product Requirements, IEC 60601, IEC 62368-1, ISO 13485, ISO 9001, and ISO 14971.
- Coordinate EMC, electrical safety, environmental, and radiation safety testing activities.
- Maintain technical files, declarations of conformity, test reports, and compliance documentation.
- Support customer regulatory requirements and provide documentation for customer submissions and market approvals.
- Monitor changes in global regulations and standards and assess impacts on products.
- Support design reviews, risk management, verification, validation, and product change assessments.
- Support internal, customer, and external audits.
- Manage relationships with testing laboratories, certification bodies, and consultants.
- Ensure compliance with RoHS, REACH, WEEE, PFAS, and Conflict Minerals requirements.
- Provide compliance guidance to Engineering, Quality, Manufacturing, and Product Management teams.
- Other duties as required.
YOU ARE THE RIGHT PERSON FOR THIS JOB IF YOU HAVE:- Bachelor's degree in Electrical Engineering, Electronics Engineering, Biomedical Engineering, or related technical discipline.
- 7+ years of experience in regulatory compliance, product safety, EMC, or related functions.
- Experience with medical electrical equipment, power electronics, high-voltage systems, or RF products.
- Strong knowledge of IEC 60601, IEC 62368-1, ISO 13485, ISO 9001, ISO 14971, EMC standards, and environmental compliance regulations.
- Experience coordinating third-party testing and certification activities.
- Strong technical writing, communication, and project management skills.
- Ability to work independently and lead cross-functional initiatives.
- Must be able to meet CGP requirements
- Limited travel to the United States and certification laboratories may be required.
WHAT WE OFFER: Whether you are a seasoned professional or just embarking on your career, CPI is an ideal place to expand your knowledge and expertise. We cultivate a healthy, dynamic, and team-oriented environment that empowers our employees to develop, create and deliver innovative, reliable technology solutions to power, connect, protect, and support a better tomorrow.
We offer our employees an attractive compensation package with competitive salaries and comprehensive benefits, including health and wellness programs, career development, generous retirement savings plan with company match and more!
This posting is for an existing vacancy.
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