Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the student debt program and education benefit - an affordable and convenient path to getting a bachelor's degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ---ngersticks.The Opportunity We currently have an exciting opportunity for a Senior Project Manager, Clinical Evaluation - China available on-site in Santa Clara, CA. In this role, you will provide project management, regulatory strategies, and medical writing expertise to support marketing applications and post-market surveillance filed with China National Medical Products Administration (NMPA). Your deliverables include Clinical Evaluation Report (CER), Periodic Risk Evaluation Report (PRER), and other related regulatory documents. Daily activities are related to managing cross-functional teams and authoring the regulatory deliverables for Vascular, Structure Heart, Cardiac Rhythm Management, Heart Failure, Neuromodulation, and Electrophysiology products.What You'll Work On
- Facilitate bilingual communication with cross-functional teams in both English and Standard Chinese/Mandarin to ensure seamless collaboration.
- Acquire and implement expertise in clinical evaluation, up-to-date China NMPA regulations, NMPA guidance, China national or medical standards, and pertinent medical and device technology fields, including clinical and non-clinical research.
- Strategize and deliberate on clinical data/evaluation-related regulatory strategies with cross-functional teams.
- Communicate with external medical writing vendors on project strategy, timelines and address any arising challenges effectively.
- Develop regulatory deliverables (CER, PRER, etc.) with support from external medical writing vendors.
- Ensure regulatory deliverables (CER, PRER, etc.) are completed on-time and within budget.
- Engage proactively in drafting responses during China NMPA's review processes to facilitate regulatory approvals.
- Provide regular project status updates to management teams.
- Manage competing and/or shifting priorities.
- Contribute to process improvement efforts.Required Qualifications
- Bachelor's Degree in related field OR an equivalent combination of education or work experience.
- Minimum 6 years related work experience with a strong understanding of specified functional area (medical devices, clinical research experience, or related industry).
- Solid understanding and application of business concepts, procedures and practices.
- Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Has a sound knowledge of a variety of alternatives and their impact on their business unit.PreferredQualifications
- Bachelor's Degree in Life Sciences; Advanced degree(s) in biomedical science, medicine, nursing, clinical/mechanical engineering, regulatory affairs, or related fields
- Full professional working proficiency in both English and Standard Chinese/Mandarin
- Relevant working experience in clinical evaluation, project management, technical/medical/regulatory writing experience, risk management, biomedical/clinical research, regulatory affairs, clinical/quality/R&D engineering, or other related experience.
- Working knowledge on relevant regulations and guidance (e.g. China State Council Order No. 739 (2021), China State Administration for Market Regulation Order No. 47 (2021), NMPA Announcement No. 73, 2021, NMPA Announcement No. 13, 2018, NMPA Announcement No. 71, 2021, NMPA Announcement No. 91, 2021, NMPA Announcement No. 77, 2020, NMPA Announcement No. 18, 2020, NMPA Announcement No. 8, 2022, IMDRF MDCE WG/ N55FINAL:2019, IMDRF MDCE WG/N56FINAL:2019, IMDRF MDCE WG/N57FINAL:2019, IMDRF GRRP WG/ N47 FINAL: 2018, IMDRF Registry WG/N33FINAL: 2016, IMDRF Registry WG/N42FINAL:2017, IMDRF Registry WG/N46 FINAL:2018, GHTF SG1/ N78:2012, GHTF SG1/ N044:2008, GHTF SG1/N011R20:2008, ISO 13485:2016, ISO 14971:2019, ISO 14155:2020, EU MDR 2017/745, MDCG guidance documents, EU MDD 90/385/EEC and 93/42/EEC, MEDDEV guidance documents, etc.)
- Excellent written, verbal and presentation skills in relevant areas of clinical/technical applications.
- Demonstrated ability to identify and adapt to shifting priorities and competing demands.
- High attention to detail with excellent organizational and interpersonal skills and ability to take charge, set objectives, drive to results* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews.The base pay for this position is $83,600.00 - $167,200.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr