Global Compliance Engineer
| Company | PerkinElmer |
|---|---|
| Location | Golden, CO, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Expert or higher |
Requirements
- Broad knowledge and application of worldwide regulatory compliance laws, directives and industry specific regulations pertaining to Product Safety, Electromagnetic Compatibility, Material compliance regulations (e.g. RoHS, REACH, Conflict Minerals)
- Familiarity with requirements for EU CE safety self-declaration including maintenance of safety files and support documentation for EU Declarations of Conformity
- Bachelor’s degree required in electrical engineering or closely related discipline
- Minimum of 10 years of recent experience compliance engineering, regulatory affairs, or product certification within the analytical instrumentation, medical devices, or industrial equipment sectors
- Strong knowledge of global regulatory frameworks, including ISO, IEC 61010, CE Marking, FDA 21 CFR, RoHS, REACH, and other relevant standards
- Excellent problem-solving, project management, and communication skills
- Ability to work cross-functionally in a global team environment
Responsibilities
- Provide compliance subject matter expertise to research and design teams for New Product Introductions and manufacturing engineering teams for existing legacy instruments
- Use technical knowledge and significant problem-solving ability to help determine the most effective solution for complex problems spanning multiple technical disciplines
- Work in conjunction with scientists and other engineers to prove out designs
- Coordinate resolution of technical issues with members of cross functional team
- Develop measures to support initiatives and strategies
- Provides technical insight to analyze risks and opportunities and adjust plans to minimize risk and maximize opportunity
- Prepare, review, and submit technical files, compliance reports, and regulatory documentation for internal and external audits
- Stay updated on emerging global regulations and industry standards and proactively implement necessary changes
- Oversee EMC, safety, environmental, and performance testing in collaboration with internal cross-functions and third-party testing organizations
- Work closely with R&D, manufacturing, and legal teams to ensure compliance is integrated throughout the product lifecycle
- Assist with internal and external audits, including responding to regulatory agencies and certification bodies
- Develop and deliver compliance training programs to ensure company-wide awareness of regulatory requirements
Preferred Qualifications
- Experience with product lifecycle management (PLM) systems and industry standard CAD packages (e.g. Solid Works, Altium) software is a plus
- Ability to evaluate and troubleshoot with standard test equipment (e.g., oscilloscopes, DVMs)