Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life POSITION SUMMARY The Principle/Senior Regulatory Affairs Specialist under Regulatory Affairs Innovative Pathway team is to provide expert clinical support on NMPA registrations, especially for planning the clinical pathway for product, clinical evaluation report (CER) preparation, and clinical regulation/guidance input on the clinical trial design/documents to support NMPA registration, etc. This position also will be responsible for the innovative special pathways for accelerating the product registration or launch in China, like the Green Channel, Prioritize Review, Boao/GBA/National level special commercial use, etc. KEY RESPONSIBILITIES 1. China Clinical Pathway for NMPA Registration · Lead and responsible for planning the clinical pathway of product registration in China, ensure the implementation &updating of clinical strategy throughout the NMPA approval cycle. · Serves as subject matter expert (SME) on China clinical regulations, provide expert clinical regulatory support to the RA team and Medtronic. 2. Clinical Evaluation Report and Global Clinical Evidence Leverage · Collaborate with global clinical/medical and cross-functional teams, ensure the CERs (including overseas clinical trial data reports) are fully compliant with the up to date NMPA requirements, Medtronic SOP & WI, and agreed timeline. · Review and approve the CER documents on behalf of China RA, communicate with NMPA on the CER deficiency requirements. · Prepare clinical evaluation materials including CER or overseas clinical data report per the clinical pathway to support timely NMPA registration. 3. Clinical Trial Regulatory Compliance · As China RA representative, review and approve the overseas/in-China clinical trial design & materials for NMPA registration, and the External Research Programs (ERPs) in China. 4. Innovative Pathway · Responsible for fully leveraging the innovative pathways (e.g. Green Channel, Prioritize review, etc.) to accelerate the NMPA registration, assess the feasibility and risk of the innovative pathway from clinical value perspective, and responsible for preparing the innovative pathway application dossiers from clinical part. · Responsible for applying the special commercial use in Boao, GBA or follow the NMPA policy. JOB QUALIFICATIONS Thorough knowledge of NMPA medical device regulations, especially clinically relevant regulations/guidance. Demonstrated ability to identify and solve problems independently. Ability to work with a cross-functional team; Effective verbal and written communication skills and presentation skills in both English and Mandarin; Proven record of successful completion of complex tasks. DESIRABLE Master’s degree in medicine, biostatistics, healthcare, public health, statistic or related area is preferred; 3 years or above experience in China clinical pathway planning, China clinical evaluation, and experience in scientific writing is highly preferred; In addition to above, experience in clinical trial design and execution, or education background of statistics is nice to have. Physical
Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com.
Benefits
& Compensation Medtronic offers a competitive Salary and flexible
Benefits
Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com