| Job Description: Regulatory Affairs Project Manager Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life, so it's equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with 93,000 other curious, creative 3Mers. "A long-lasting career at 3M comes from having vision, imagination and the ability to see what doesn't exist. 3Mers are groundbreaking innovators and it's important that we give every person the space for disruptive and creative thinking." - John Banovetz, senior vice president and chief technology officer at 3M This position provides an opportunity to transition from other private, public, government, or military environments to a 3M career. The Impact You'll Make in this Role This role has responsibility for leading cross-functional teams to support growth initiatives in the Oral Care Solutions Division by ensuring our legacy products meet global regulatory requirements, including the EU Medical Device Regulation, and coordinating strategic global registrations in China.
As a Regulatory Affairs Project Manager, 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: - Providing Project Management leadership to drive Regulatory projects important to the Oral Care Solutions Division
- Developing a list of prioritized projects to meet evolving regulatory requirements for legacy products.
- Working with the marketing team to align on prioritized products.
- Determining direct and indirect costs of prioritized projects.
- Driving execution of end-to-end EU MDR implementation, such as SKU creation, label and IFU review, plant execution, change control documentation, data syndication, inventory phase in/phase out, and customer communications.
- Managing timelines for strategic regulatory submissions in China.
- Tracking and communicating progress to division, HCBG, and international stakeholders.
- Providing direction to working groups and remove barriers.
Your Skills and Expertise
To set you up for success in this role from day one, 3M is looking for (at a minimum) the following qualifications: - Bachelor's degree or higher (completed and verified prior to start) from an accredited institution
- Five (5) years' experience in a health care business within a private, public, government or military environment
Additional qualifications that could help you succeed even further in this role include: - Bachelor's degree or higher in a health sciences or engineering discipline from an accredited institution
- Knowledge of processes in health care quality systems
- Ten (10) years' experience in a health care business within a private, public, government or military environment
- Familiarity with Power BI, advance Excel skills
- Research and Development experience
- Conversational fluency in Mandarin
- Effectively communicate to all levels
- Detailed oriented
Travel: May include up to 10% domestic/international Relocation Assistance: Is not authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Responsibilities of this position may include direct and/or indirect physical or logical access to information, systems, technologies subjected to the regulations/compliance with U.S. Export Control Laws.
U.S. Export Control laws and U.S. Government Department of Defense contracts and sub-contracts impose certain restrictions on companies and their ability to share export-controlled and other technology and services with certain "non-U.S. persons" (persons who are not U.S. citizens or nationals, lawful permanent residents of the U.S., refugees, "Temporary Residents" (granted Amnesty or Special Agricultural Worker provisions), or persons granted asylum (but excluding persons in nonimmigrant status such as H-1B, L-1, F-1, etc.) or non-U.S. citizens.
To comply with these laws, and in conjunction with the review of candidates for those positions within 3M that may present access to export controlled technical data, 3M must assess employees' U.S. person status, as well as citizenship(s).
The questions asked in this application are intended to assess this and will be used for evaluation purposes only. Failure to provide the necessary information in this regard will result in our inability to consider you further for this particular position. The decision whether or not to file or pursue an export license application is at 3M Company's sole election. Supporting Your Well-being 3M offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope. Resources for You For more details on what happens before, during and after the interview process, check out the Insights for Candidates page at 3M.com/careers. Learn more about 3M's creative solutions to the world's problems at www.3M.com or on Twitter @3M. Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. 3M is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. 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. 3M Global Terms of Use and Privacy Statement
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