Regulatory Compliance Officer
3 weeks ago
Job Title: Regulatory Compliance Officer
Department: Electrical Engineering
Reports to: Director of Electrical Engineering
Overview: THIS IS NOT A DATA or SOFTWARE COMPLIANCE ROLE- IT IS IN MEDICAL INSTRUMENT MANUFACTURING.
We are seeking a knowledgeable and detail-oriented Regulatory Compliance Officer to join our Electrical Engineering Department. The ideal candidate will have extensive experience in regulatory compliance, particularly with EMC-Safety, UL/CSA/IEC 61010, EN 61326, and FCC part 15 standards, and will play a critical role in ensuring our product designs, testing, and manufacturing processes meet global regulatory requirements. Demonstrated experience in EMC and Product Safety a must.
Responsibilities:
- Serve as an expert in global compliance, with a focus on UL/CSA/IEC 61010, EN 61326, and FCC part 15 standards.
- Review hardware designs to ensure compliance with relevant safety and electromagnetic compatibility (EMC) regulations.
- Conduct tests and create official UL/CSA/IEC 61010 Technical Report Forms (TRFs) to confirm compliance.
- Represent the company during UL/CSA/IEC 61010 audits conducted by Nationally Recognized Testing Laboratories (NRTLs).
- Maintain communication with global regulatory agencies to ensure ongoing compliance and stay updated on any changes to regulatory frameworks.
- Write and maintain safety and EMC testing procedures.
- Mentor and train junior engineers in compliance and safety best practices.
Qualifications:
This position is Mandatory On-Site in Reno, NV- Relocation Costs are Fully Covered
- Bachelor's degree in Electrical Engineering/Mechanical Engineering from an accredited, not-for-profit university (Master's degree preferred).
- Minimum of 8 years of compliance experience with UL/CSA/IEC 61010, EN 61326, or FCC part 15 (or 5 years of experience with a Master's degree).
- Strong technical knowledge and understanding of product and process design.
- Excellent communication skills, both verbal and written, with a proven ability to explain complex ideas.
- Ability to write detailed reports and develop compliance procedures.
- Interpersonal skills to effectively communicate and build partnerships with external regulatory agencies.
Additional Information:
- The company has a diverse portfolio of innovative design projects, providing ample opportunities for professional growth.
- We are committed to sustainability and safety, with rigorous safety testing and certification processes.
- We offer competitive compensation, along with medical, dental, vision insurance, paid vacation and sick time, disability insurance, 401k, tuition reimbursement, and more. Relocation Costs are Covered by the Client.
- Candidates must pass drug and background screenings.
- Personal Protective Equipment (PPE) may be required and will be provided by the employer.
Note: This job requires a high level of EMC safety compliance and an ongoing commitment to maintaining certification with Global EMC Safety, UL and CSA standards. The successful candidate will play a key role in ensuring the safety and quality of our products, fostering confidence among users and regulatory authorities.
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