Regulatory Affairs Specialist
4 weeks ago
At Siemens, we're committed to creating a more connected and caring world through our smart infrastructure solutions. As a Regulatory Affairs Professional, you'll play a crucial role in ensuring our products meet the highest standards of quality, safety, and regulatory compliance.
Key Responsibilities:- Create and maintain quality guidelines and work instructions to ensure regulatory compliance.
- Identify and analyze country-specific requirements for product submissions and implement necessary changes.
- Plan and prepare product-related submissions with internal and external organizations according to regulatory requirements.
- Perform regulatory projects and provide support to project steering groups.
- Submit required documentation to local authorities, foreign certifying agencies, and internal teams.
- Initiate and escalate necessary activities in case of deviations.
- Ensure creation of adequate documentation for audits and inspections.
- Perform training within the organization on country-specific regulatory requirements.
- Review promotional material for regulatory compliance according to country-specific requirements.
- Represent the company in industry associations and support new product certifications.
- Knowledge of product standards IS/IEC60898, IS 12640 pt.1 & pt.2, IS/IEC60947, and IS/IEC 60269.
- Ability to handle international certifications like CCC, VDE, UL, DNV, LR, ESC, EAC, INMETRO, and S Mark.
- Experience in supplier visits and maintenance of product certifications.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
Siemens is a global leader in the energy and infrastructure sectors, committed to creating a more connected and caring world. We value diversity and equality and welcome applications from candidates who reflect the diversity of our communities. Join us in shaping the future of smart infrastructure and making a positive impact on the world.
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