Senior Global Compliance Engineer

PerkinElmer; Ontario; On-site; CAD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Senior Global Compliance Engineer to join their innovative R&D team. This role is pivotal in ensuring that new product developments and existing instruments meet international regulatory standards. You will leverage your extensive knowledge of compliance requirements to work closely with product development and quality assurance teams, fostering collaboration across various functions. This position offers the chance to make a significant global impact while working with cutting-edge analytical instrumentation in a dynamic and inclusive environment that promotes career growth. If you are passionate about compliance and eager to contribute to scientific advancements, this opportunity is perfect for you.

Benefits

Competitive salary

Benefits

Professional development programs

Collaborative work environment

Qualifications

• 10+ years of experience in compliance engineering or regulatory affairs.
• Strong knowledge of global regulatory frameworks and standards.
• Ability to work cross-functionally in a global team environment.

Responsibilities

• Ensure compliance of new products with international regulatory standards.
• Collaborate with cross-functional teams on compliance processes.
• Prepare and submit technical files and compliance reports.

Skills

Regulatory Compliance

Problem-Solving

Project Management

Communication Skills

Technical Documentation

Education

Bachelor's Degree in Electrical Engineering

Tools

Solid Works

Altium

Word

Excel

PowerPoint

Visio

Job description

Senior Global Compliance Engineer

Job Type: Full Time

Career Level: Experienced (non-manager)

Education: Bachelor’s Degree

The Company

The “new” PerkinElmer business, a newly independent company as of March 13, 2023, is a global analytical services and solutions provider with offerings including the leading OneSource Field and Laboratory services business that serve the biopharma, food, environmental, safety and applied end markets to accelerate scientific outcomes. Since 1937, PerkinElmer has served as a trusted partner in laboratory analysis and management and today complements its service offerings with a broad portfolio of atomic spectroscopy, molecular spectroscopy, and chromatography instruments, consumables, and reagents. With a dedicated team of more than 6,000 team members, the Company serves customers in more than 35 countries. Additional information is available at www.perkinelmer.com.

Purpose

PerkinElmer is seeking a highly motivated and experienced Global Compliance Engineer with laboratory instrument knowledge to join our dynamic and growing R&D team. As a Global Compliance Engineer, you will be accountable for ensuring new product development projects and our existing instrumentation throughout their lifecycle meet all international regulatory standards and certifications. This position requires a deep understanding of global compliance requirements, including ISO, CE, FCC, UL, RoHS, REACH, and other industry-specific standards. You will work cross-functionally with product development, quality assurance, and legal teams to ensure seamless compliance processes for both existing and new products. The successful candidate will collaborate with global cross-functional teams, ensuring effective communication and coordination throughout project lifecycles. The position reports into PerkinElmer’s R&D organization based in Woodbridge (Greater Toronto Area), Ontario, Canada.

Key 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.
• Documentation & Reporting: Prepare, review, and submit technical files, compliance reports, and regulatory documentation for internal and external audits.
• Standards & Risk Management: Stay updated on emerging global regulations and industry standards and proactively implement necessary changes.
• Testing & Validation: Oversee EMC, safety, environmental, and performance testing in collaboration with internal cross-functions and third-party testing organizations.
• Cross-Functional Collaboration: Work closely with R&D, manufacturing, and legal teams to ensure compliance is integrated throughout the product lifecycle.
• Audit Support: Assist with internal and external audits, including responding to regulatory agencies and certification bodies.
• Training & Education: Develop and deliver compliance training programs to ensure company-wide awareness of regulatory requirements.

Technical Requirements (Compliance Engineer)

• Role requires 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
• Experience with Lab and Measurement Equipment (MEAS) category preferred, Industry standards 61010-1, 61326-1
• Act as liaison with Product Development teams and contract, Agency laboratories
• Participate on New Product Development design reviews to provide insight and advice on design choices as they pertain to regulatory compliance standards
• Maintain 3rd party Agency files for safety testing through audits, file changes and inspection payments
• Create EMC test plans and maintain EMC files and support documentation for Korean RRA, Australian ACMA, FCC and CE self-declaration.
• Possess a thorough understanding of the RoHS, and REACH regulations, sound engineering knowledge of materials and an appreciation of the design process.
• Knowledge of manufacturing and assembly processes to help develop designs which are compliant to regulatory requirements, cost-effective and reliable.
• Ability to evaluate and troubleshoot with standard test equipment (e.g., oscilloscopes, DVMs)
• Possesses a strong knowledge of EMI-EMC management techniques to pass standardized testing of electronic equipment.
• Ability to use standard documentation tools to create/communicate design and test specifications/results (e.g., Word, Excel, PowerPoint, Visio).

Expertise Required

• 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.
• Experience working with certification bodies and regulatory agencies worldwide.
• Familiarity with EMC, electrical safety, and environmental compliance testing.
• Excellent problem-solving, project management, and communication skills.
• Ability to work cross-functionally in a global team environment.
• Experience with product lifecycle management (PLM) systems and industry standard CAD packages (e.g. Solid Works, Altium) software is a plus.
• Demonstrated ability to succeed in a fast-paced environment while working on multiple projects with constantly changing priorities and deadlines.

Why Join Us?

• Work with state-of-the-art analytical instrumentation in a growing and innovative industry.
• Opportunity to make a global impact on compliance and regulatory strategy.
• Collaborative and inclusive work environment with career growth opportunities.
• Competitive salary, benefits, and professional development programs.

PerkinElmer is an equal opportunity employer.