Regulatory Affairs Specialist at Siemens Healthineers

, , China -

Full Time

Start Date

Immediate

Expiry Date

18 Jul, 26

Salary

0.0

Posted On

20 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Regulatory Compliance, Documentation, Quality Guidelines, Regulatory Submissions, Auditing, Inspection Preparation, Training, Promotional Material Review, Project Management, Lobbying, Medical Technology

Industry

Hospitals and Health Care

Description

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.* Creates quality guidelines and work instructions relevant for maintaining regulatory compliance. * Identifies, analyzes and implements country specific requirements necessary for product related submissions. * Plans and prepares product related submissions with Siemens internal (e.g. Branch Countries) or external organizations according to regulatory requirements. * Performs regulatory projects or acts as a member of the project steering group. * Submits required documentation/information to local authorities or Siemens internal. * Initiates and escalates necessary activities if deviations are identified. * Ensures creation of adequate documentation for audits/inspections. * Performs training within the organization in country specific regulatory requirements, if applicable. * Performs review of promotional material for regulatory compliance according to country specific requirements. * May represent the company in industry associations (Lobbying), if applicable. Who we are: We are a team of more than 72,000 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. To find out more about Healthineers’ specific businesses, please visit our company page here. As an equal opportunity employer, we welcome applications from individuals with disabilities. Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile where you can upload your CV. Setting up a profile also lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started. Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site. To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes. As an equal opportunity employer, we welcome applications from individuals with disabilities. We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

Responsibilities

The Regulatory Affairs Specialist is responsible for preparing product-related regulatory submissions and ensuring compliance with country-specific requirements. They also manage documentation for audits, perform internal training, and review promotional materials for regulatory adherence.