Regulatory Specialist

**Shaping the future through innovation and discovery**

With a history spanning more than seven decades, Communications & Power Industries’ thousands of products have impacted people’s lives in numerous unseen ways every day. Our highly engineered products serve as the backbone of modern-day commercial and military communications systems, aid in the treatment of cancer, assist in diagnosing medical conditions, support and protect soldiers, sailors, and pilots, empower scientific discoveries and space exploration, help ensure the safety of imported foods and materials, and much more.

CPI is headquartered in Palo Alto, California and is a global manufacturer of electronic components and subsystems. We have manufacturing locations in the United States, Canada, Europe, and Asia. With a heritage of technological excellence, our team serves customers in the communications, defense, medical, industrial, and scientific markets.

**Job Summary**

Work in the Quality Assurance Department to ensure the Regulatory Compliance for Power Electronics (PE) Georgetown’s VED, Solid State, Medical and Airborne products.

**YOU WILL BE ACCOUNTABLE FOR**:

- Determine the requirements to meet product environmental, health, and safety regulations and standards.
- Provide guidance to engineering regarding EMC and electrical safety testing to comply with the appropriate standards.
- Participate in design and engineering change reviews to assess risk and the need to notify the regulatory bodies of significant changes in the product.
- Stay current with revisions of the applicable regulations and standards in key markets i.e., EU, Canada, and the US.
- Investigate the requirements for complying with the regulations in other parts of the world required to sell products.
- Prepare and maintain product regulatory submission packages, technical files, product declarations, and other documentation required by specific agencies and regulatory bodies to ensure conformity of the devices before market release.
- Support foreign mandated Authorised Representatives to ensure timely technical submissions.
- Ensure compliance to the post market surveillance requirements of the regulatory bodies.
- Support external audits by the regulatory agencies and conduct internal audits, as needed.
- Lead continuous improvement activities related to regulations and standards to grow the portfolio of certifications in support of evolving business needs.

**YOU ARE THE RIGHT PERSON FOR THIS JOB IF YOU HAVE**:

- Bachelor’s degree in mechanical or electrical engineering with relevant work experience.
- Demonstrated technical competency in APQP and PPAP process, tools, and techniques.
- Proficient knowledge of product development (engineering, hardware, software, manufacturing, testing, supply chain, etc.).
- Competency in ISO 13485, ISO 9001, MDSAP, CE Mark, and FDA requirements.
- Knowledge of CBAM, WEEE, and POP requirements is desired.
- Experience working in a manufacturing environment with vacuum electron devices, medical generators, or solid-state power amplifiers is a plus.
- Expert knowledge of quality assurance, quality control, and continuous improvement methodologies.
- Proficiency in use of root cause analysis and statistical methods.
- Previous experience with supplier chain and project management.
- Proficiency in communicating issues, impact, and corrective
- Excellent interpersonal skills in working with internal and external stakeholders.

**Security**
- Must meet all CGP and ITAR requirements.

**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

**WHO WE ARE**:
We value the unique and diverse skills, qualities, and backgrounds that each employee brings to CPI, and we respect each employee as an integral member of our growing team. CPI is committed to providing equal employment opportunities for all current and prospective employees, as well as to promoting a culture of inclusion and respect for everyone. We celebrate the innovation that diversity creates in the work environment, and we recognize that each employee brings their own unique capabilities, experiences, and perspectives to the organization. It is this variety that adds value to our teams, as well as to our stakeholders. We welcome and encourage applicants to reach their full potential with us.