Regulatory Affairs Specialist

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Analyzes the requirements and prepares product related regulatory submissions.

Major Responsibilities:

• Coordinate, prepare, or review regulatory submissions plan and strategy for domestic or international registration projects.
• Work together with global and local cross functions for all NMPA registration activities include type testing, technical documents preparation, submission and assure scientific rigor, accuracy, and clarity of presentation to achieve NMPA registration certificate in fast and effective way
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Review clinical materials to ensure collection of data needed for regulatory submissions.
• Maintain or develop good working relationships and cooperation with relevant authorities like test labs, CMDE etc. to improve working efficiency.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
• Interpreting NMPA regulation requirements or regulation changes and ensuring that they are communicated through corporate policies and procedures.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Compile and maintain regulatory documentation databases or systems. Recommend changes to company procedures in response to changes in regulations or standards.
• Review product promotional materials, labeling, specification sheets, or test methods for compliance with applicable regulations and policies.
• Write or update standard operating procedures, work instructions, or policies.
• Participate in internal or external audits if required.
• Other tasks assigned by management

Qualifications

• Minimum 5 years working experience as regulatory affairs specialist for medical device
• Bachelor of Science / Engineering, e.g. biomedical engineering etc.
• English as working language
• Work experience in the active medical device industry.
• Excellent communication skills – ability to engage fluidly between levels in the organization and between cultures
• Good project management skills: registration planning, submission preparation tracking, registration project risk management, stakeholder management
• Preferred: Business level proficiency of English.
• Proficient in utilizing business tools, such as e-mail, Word, Excel, PowerPoint, and project management tools, like MS Project.

Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

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