BD Nogales Norte · 3 weeks ago
Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)
United States
Full-time
Remote
Mid, Senior Level
$81K/yr - $133K/yr
5+ years expBD is one of the largest global medical technology companies in the world, and they are seeking a Senior Specialist in Regulatory Affairs to ensure compliance for their Advanced Patient Monitoring product portfolio. This role involves supporting regulatory submissions, maintaining product compliance, and providing guidance to cross-functional teams for the China regional market.
Consumer Goods
Responsibilities
Support regional Regulatory team to provide design dossiers, technical writings for NMPA submissions
Interpret and apply applicable regulations, standards, and guidance documents (e.g., GB/YY standards, NMPA guidance documents) to product development, manufacturing, and post-market activities
Serve as a regulatory subject matter expert for product development teams, providing guidance on regulatory strategies, design controls, risk management, and labeling requirements
Support post-market surveillance activities, including adverse event reporting, field actions, and regulatory responses to health authority inquiries
Review and approve labeling for regional expansion
Participate in internal and external audits
Collaborate effectively with cross-functional teams including R&D, Quality, Marketing, and manufacturing sites to achieve regulatory objectives
Qualification
Required
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, specifically for Class II and/or Class III electronic or vascular products for the China, Hong Kong, and Taiwan regulatory agencies
Strong understanding of China, Hong Kong and Taiwan medical device regulations
Demonstrated experience in preparing and submitting APAC regulatory filings, supporting type testing
Sound understanding of design control processes
Proven experience collaborating cross-functionally with R&D, Quality, and Manufacturing teams
Demonstrated ability to lead and manage complex regulatory projects across multiple departments and stakeholders, ensuring compliance with global standards, alignment of objectives, timely execution, and successful outcomes that support product approvals and submissions
Excellent written and verbal communication skills, with the ability to articulate complex regulatory requirements clearly and concisely
Proven ability to work independently and as part of a team in a fast-paced, dynamic environment
Strong analytical and problem-solving skills, with keen attention to detail
Proficient with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook and Teams)
Ability to travel occasionally as required (less than 10%)
Preferred
Advanced degree (Master's or Ph.D.) preferred not required
Benefits
Competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD Nogales Norte
Somos una empresa multinacional dedicada a la manufactura de dispositivos de uso médico a través de los cuales seguimos impulsando el mundo de la salud.
1001-5000 employees
H1B Sponsorship
BD Nogales Norte has a track record of offering H1B sponsorships. Please note that this does not
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2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Late StageCompany data provided by crunchbase