BD

Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)


This job is now closed

Pay$80600.00 - $133000.00 / year
LocationIrvine/California
Employment typeFull-Time
  • Job Description

      Req#: R-532635
      Employer Industry: Medical Technology

      Why consider this job opportunity:
      - Salary up to $133,000 annually
      - Opportunity for career advancement and growth within the organization
      - Flexibility to work remotely within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones
      - Supportive and collaborative work environment that values contributions and opinions
      - Chance to make a positive impact in the healthcare industry through innovative solutions

      What to Expect (Job Responsibilities):
      - Support the regional Regulatory team in providing design dossiers and technical writings for regulatory submissions
      - Interpret and apply relevant regulations and standards to product development, manufacturing, and post-market activities
      - Serve as a regulatory subject matter expert, providing guidance on regulatory strategies and compliance
      - Support post-market surveillance activities, including adverse event reporting and regulatory responses
      - Collaborate with cross-functional teams to achieve regulatory objectives and ensure product compliance

      What is Required (Qualifications):
      - Bachelor's degree in a scientific or technical discipline such as Biomedical Engineering, Chemistry, Biology, Pharmacy, or Regulatory Affairs
      - Must be fluent in Mandarin Chinese and English (read, write, and speak)
      - Minimum of 5 years of experience in Regulatory Affairs within the medical device industry
      - Strong understanding of medical device regulations in China, Hong Kong, and Taiwan
      - Proven experience collaborating with R&D, Quality, and Manufacturing teams

      How to Stand Out (Preferred Qualifications):
      - Advanced degree (Master's or Ph.D.) in a related field

      #MedicalTechnology #RegulatoryAffairs #CareerOpportunity #RemoteWork #HealthcareInnovation

      "We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."
  • About the company

      210136 Becton, Dickinson and Company, commonly known as BD, is an American multinational medical technology company that manufactures and sells medical devices, instrument systems, and reagents.

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