[Remote] Senior Specialist, Regulatory Affairs (bilingual Mandarin Chinese)

Note: The job is a remote job and is open to candidates in USA. BD is one of the largest global medical technology companies in the world, dedicated to advancing health through innovative solutions. The Senior Specialist, Regulatory Affairs is responsible for ensuring regulatory compliance for BD’s Advanced Patient Monitoring product portfolio, supporting regulatory submissions, and providing strategic guidance to cross-functional teams in the China regional market. 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 Skills • 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%) • Advanced degree (Master's or Ph.D.) preferred not required Benefits • A valuable, competitive package of compensation and benefits programs • Rewards and recognition opportunities that promote a performance-based culture Company Overview • BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions. It was founded in 1897, and is headquartered in Franklin Lakes, New Jersey, USA, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship • BD has a track record of offering H1B sponsorships, with 66 in 2023, 4 in 2022, 3 in 2021. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job