Medical Device Regulatory Specialist

4 days ago


Santa Clara, California, United States Abbott Laboratories Full time
Job Overview

Absolutely crucial to the success of our medical device technologies is a dedicated team of regulatory specialists. If you have a passion for clinical evaluation, a strong understanding of business concepts and practices, and excellent written, verbal, and presentation skills, we want to hear from you

About Abbott Laboratories

Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

Responsibilities
  • 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)
  • Develop Clinical Evaluation Report (CER), Periodic Risk Evaluation Report (PRER), and other related regulatory documents
  • Facilitate bilingual communication with cross-functional teams in both English and Standard Chinese/Mandarin to ensure seamless collaboration
  • 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
Requirements
  • 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.)
Salary Range

$83,600.00 – $167,200.00



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