Senior Manager, Regulatory Affairs Operations responsible for regulatory submissions in a biotechnology firm. Overseeing documentation, compliance, and cross - functional collaboration for FDA and EMA submissions.
About the role
- Certification Engineer leading product certification efforts for actuators across industries. Preparing documentation, collaborating with certification agencies, and ensuring compliance standards are met.
Responsibilities
- Manage certification projects for a variety of actuator products.
- Prepare technical documentation for submission to regulatory and certification bodies (e.g., UL, CSA, IECEx, ATEX, PESO, CCC).
- Serve as the primary point of contact with third-party testing labs and certification agencies.
- Review and interpret product standards and ensure compliance throughout the product lifecycle.
- Support design teams in developing products that meet certification requirements. R&D tests on prototypes for early-stage findings in new product design cycle.
- Provide product improvements and test conclusion recommendations to the project teams.
- Maintain records and documentation for internal audits and regulatory inspections.
- Provide technical support during inspections, audits, and certification renewals.
Requirements
- Bachelor’s degree in Electrical Engineering, Mechanical Engineering, or a related discipline.
- Minimum of 2 years of experience in product compliance, testing, or certification (experience with hazardous location equipment is a plus).
- Proven experience collaborating with certification agencies such as UL, CSA, FM, TÜV, etc.
- Exceptional attention to detail with a systematic and analytical approach to testing and compliance.
- Highly self-motivated, able to work independently with minimal supervision.
- Demonstrated efficiency, reliability, and strong commitment to schedule adherence.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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