Sr. Officer, Regulatory Affairs,SH at Solventum · Shanghai

Sr. Officer, Regulatory Affairs,SH Location: CN, Shanghai Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You’ll Make in this Role In this position of senior officer, regulatory affairs, you will have the opportunity to act as the lead for regulatory affairs on cross functional teams and have ownership of product line submissions, registrations and QMS audits in China NMPA, for the Dental Solutions business. The position will work with the international regulatory affairs group to ensure products are registered based on the business strategy. In addition, you will have the opportunity to support labeling and registration changes to due the company spin-off. As a(n) Senior Officer, Regulatory Affairs, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Leading & conducting NPI projects registrations for imported and localized medical devices. Conducting regulatory change assessments and coordinating associated. Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality in addition to excellent organizational, prioritization, oral and written communication skills. Providing regulatory review of technical reports, BER, CER and documents. Providing contributions for development and implementation of regulatory processes. Documenting and managing metrics. Leading regulatory filings as needed for assigned projects. Supporting risk management activities, vigilance reporting activities, and other quality related initiatives with minimal oversight. Leading the implementation of key corporate initiatives and appropriate tools. The job also requires performing other duties as assigned. Percentages of time spent on job duties are estimates and may vary for each position. A successful candidate for this role: Possesses thorough understanding of concepts and professional practices to solve complex and diverse regulatory problems. Has exceptional attention to detail, written and oral communication skills. Utilizes strong technical and non-technical communication skills of listening, reading, writing, and speaking and continuously improves upon these skills through regular participation in appropriate training activities. Maintains broad knowledge of assigned organization's products, broad industry trends, and customer needs. Capable of developing understanding of technologies and/or products across multiple divisions. Possesses knowledge of and regularly utilizes available information resources and systems. Collaborates with colleagues to innovate, influence, and/or negotiate when required. Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: Bachelor’s Degree or higher from an accredited university such as Biology, Chemistry, Biomedical Engineering or a related technical/health care field. 8+ years in regulatory affairs in the medical device industry. Direct experience authoring submissions/technical documentation for imported and localized medical devices. Direct experience authoring regulatory strategies, regulatory change assessments and gap analysis. Direct experience revising, reviewing and approving labeling (including marketing claims) that meet regulatory requirements. Must have experience and expertise in design control verification and validation activities, as well as expertise in CER requirements for medical devices; in particular, experience with assisting teams with documenting and performing to applicable requirements, and assisting with writing, reviewing and approving all protocols and reports. Expert Chinese and English technical writing capabilities. Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite Work location: Maxdo, Shanghai,Onsite Travel: Subject to job requirements Supporting Your Well-being Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. global job description. Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.  Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. 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