GE HealthCare Safety Regulatory Engineer 

Sweden 

492965476

You will be responsible for ensuring that the products we develop comply with regulatory requirements as defined by the local regulatory leader, covering the entire product lifecycle from initial concept to discontinuation.
This role involves monitoring compliance while also conducting training across the organization to ensure that all requirements are clearly understood and consistently met.Your responsibilities will encompass the entire RP Tracer Center business product portfolio.Assignments includes, but are not limited to:

Responsibility for verifying that the products we develop meet regulatory requirements defined by local regulatory leader, throughout the complete product lifecycle, from feasibility to EOL

• Surveil but also conduct training to the surrounding organization making sure all requirements are understood and met.
• Stay constantly updated on changed and new regulations and reach out to, and collaborate with colleagues in GE operations outside Uppsala, to seek best practices and share knowledge
• Responsibility covers the whole RP Tracer Center business product portfolio

Rolse and Responsiblities:

• Responsible to ensure that safety and regulatory requirements, as set by RA, are met for the products
• Responsible for the local risk management process for our products
• Supervise, review, and approve to ensure that the design meets and/or exceeds our safety and regulatory requirements
• Actively participate in the planning and execution of new development projects
• Support product changes to maintain safety and regulatory requirements
• Support EHS activities as required
• Ensure compliance/closure of Regulatory and Quality requirements before Design Control FDRs and NPI program milestones, are approved.
• Identify opportunities and drive for continuous improvement of engineering processes that impacts Safety and Regulatory, and their templates.
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Support cross business teams to improve established processes and metrics.
• Comply with EHS regulations and policies
• Plan, organize and facilitate third party, or internal certification testing.
• Support GEMS PET cross business with risk assessment guidance and surveillance when required.

Required Qualifications:

• Bachelor’s degree in Engineering or Technology related field
• Practical experience in safety and regulatory for an engineering environment
• Strong knowledge of CE marking process including EU directives and strong knowledge of harmonized standards (e.g. IEC61010 Laboratory Equipment and EMC 61326-1), and relevant international standards
• Strong working knowledge of Cyclotron products
• Strong documentation skills
• Strong oral and written communication skills: Swedish and English
• Demonstrated LEAN and Six Sigma skills

Desired characteristics:

• Strong analytical and quantitative skill
• Drive and desire to stay up to date with safety and regulatory requirements and documentation
• Demonstrated project management, project planning and scheduling skills
• Desire to stay proficient in new and existing quality control, design processes and tools, including the ability to reach out in the global organization
• Self-starter, energizing, results oriented, and able to multi-task
• Strong team-player, interpersonal. communication and influencing skills

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world changing realities. Our salary and benefits are everything you would expect from an organization with global strength and scale. You will be surrounded by career opportunities in a culture that fosters care, collaboration and support.