Regulatory Compliance Officer

4 weeks ago

Reno, United States Evolve Full time

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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