Senior Project Manager, Clinical Evaluation - China (on-site)

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.

Preferred Qualifications

• 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
30+ days ago