As a member of the Regulatory Affairs Department the Systems Regulatory Compliance Engineer will be part of the Hardware products Global Market Access team, responsible for escorting hardware design, certifying products towards global standards, verifying health and environmental regulations compliance, and testing for electromagnetic & radio compatibility.
Essential Duties and Responsibilities:
To monitor, interact, report, and support R&D, Engineering, and regional teams that inquire about aspects of compliance matters, enforcement actions, remedial activities, and regulatory compliance affairs.
Lead product evaluations and tests by operating external laboratories, advisors, and subcontractors to meet relevant Safety, EMC, and Environmental certifications.
Perform product safety reviews, and preliminary safety testing, facilitate agency inspections, and maintain product regulatory compliance files.
Evaluate regulatory trends and revisions.
Preparation of Technical files including the creation of a Critical Component List
Essential Duties and Responsibilities:
To monitor, interact, report, and support R&D, Engineering, and regional teams that inquire about aspects of compliance matters, enforcement actions, remedial activities, and regulatory compliance affairs.
Lead product evaluations and tests by operating external laboratories, advisors, and subcontractors to meet relevant Safety, EMC, and Environmental certifications.
Perform product safety reviews, and preliminary safety testing, facilitate agency inspections, and maintain product regulatory compliance files.
Evaluate regulatory trends and revisions.
Preparation of Technical files including the creation of a Critical Component List
Requirements:
5+ years of prior experience at a multidisciplinary / Medical device companies
CE marking experience with a deep understanding of at least one of the following directives/regulations: Machinery, Low Voltage, Radio, and EMC directives.
Experience with safety risk assessment for complex systems, signal integrity, and system design for compliance.-nice to have
Electricity / Electronics / Electromechanics Engineering or practical Engineering degree.
Strong written and verbal English.
Ability to develop and maintain effective working relationships on a multi-level basis.
Ability to present technical information and effectively communicate across all levels of the organization.
Ability to work in a multi-tasking environment with a variable priority setting.
External Focus: Understanding customer needs, industry trends, and the industry's competitive landscape.
Auto detect and self-learner
5+ years of prior experience at a multidisciplinary / Medical device companies
CE marking experience with a deep understanding of at least one of the following directives/regulations: Machinery, Low Voltage, Radio, and EMC directives.
Experience with safety risk assessment for complex systems, signal integrity, and system design for compliance.-nice to have
Electricity / Electronics / Electromechanics Engineering or practical Engineering degree.
Strong written and verbal English.
Ability to develop and maintain effective working relationships on a multi-level basis.
Ability to present technical information and effectively communicate across all levels of the organization.
Ability to work in a multi-tasking environment with a variable priority setting.
External Focus: Understanding customer needs, industry trends, and the industry's competitive landscape.
Auto detect and self-learner
This position is open to all candidates.
