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System Engineer – Legal and Compliance

Job Description

Job Profile :
• Responsible for leading the efforts in the coordination and management of standards compliance activities for assigned programs
• In depth knowledge and skill set about international standards (IEC, EN & ISO standards for medical devices) used for International Certifications. The standards include but not limited to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 60601-1-8, UL 2900 (Cyber Security), ISO 14971, IEC 62304, IEC 60601-2-25, IEC 80601-2-30, IEC 60601-2-34 and/or any additional particular standards.
• Good Knowledge of regulatory standards and processes and submit regulatory paperwork required for FDA and CE (EU-MDR) mark certifications for the healthcare/Medical Devices
• Knowledge in SaMD (Software as a Medical Device) Regulation is desirable.
• Good knowledge of the regulatory requirements, future trends, technical and certification process requirements for USA, CANADA, EUROPE, ASEAN & OTHER markets (e.g. EU, UL, Canada, Korea, Japan, Australia/New Zealand). 
• Facilitate and coordinate input from multiple cross-functional partners including program management, QT teams, R&D, manufacturing sites and service locations to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results, partner with certification agencies and work with vendors for procuring various test reports for the accessories.
• Demonstrated experience interfacing with regulatory agencies, conformity assessment bodies (UL, CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).
• Reviews changes to the external standards and conveys impact to organization. Keep up to date of changes to product standards and regulations affecting medical products.
• Ensures ongoing compliance with the standards via review of all product changes.
• Requirement elicitation and development of the system functional specification.
• Provide Requirement Engineering with an emphasis on medical device hardware, oversee, monitor, and support feature development from inception through all testing phases (system integration, verification, & validation). 
• Perform verification testing of requirements during sprints and system integration test phases.
• Participate in Change Control Board (CCB) and coordinate change requests and defect reports
• Support the realization process to ensure proper requirements implementation. This includes but is not limited to requirement clarifications, design reviews etc.
• Ability to work as an individual contributor.
• Occasional domestic and international travel required.
• Experience or working knowledge of angiography and/or hemodynamics and/or electrophysiology domain is desirable.
• Knowledge of Quality standards in Medical Devices is desirable.
• Experience in participating in project/product Audits.

Required Knowledge/Skills, Education, and Experience:
• Bachelor’s Degree in Biomedical Electronics/Engineering, Electrical Engineering, Systems Engineering, or related field required.  Master’s degree a plus.
• 10 plus years of experience in Medical Device/System and minimum of 6+ years of experience in Regulatory Affairs.
• Strong interpersonal, written, and verbal communication skills in an English-speaking international workplace (USA, Germany, & India).
• Strong analytical, and decision-making skills
• Positive attitude and responsible, Ownership mindset
• Ability to organize, track and account for tangible deliverables.
• Ability to influence and convince others
• Occasional domestic and international travel required

Organization: Siemens Healthineers

Company: Siemens Healthcare Private Limited

Experience Level: Experienced Professional

Job Type: Part-time

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