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Job Description Summary

Job Description

We are **the makers of possible**

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a **maker of possible** with us.

Job Summary

The Senior Specialist, Regulatory Affairs plays a key role in ensuring Becton, Dickinson and Company's medical devices and Advanced Patient Monitoring Business Unit. This position involves supporting regulatory submissions, maintaining product compliance, and providing regulatory guidance to cross-functional teams for our China regional market.

The **Bilingual Mandarin Chinese and English** **Senior Specialist, Regulatory Affairs** plays a critical role in ensuring regulatory compliance for **BD’s Advanced Patient Monitoring (APM) product portfolio** . This position is responsible for supporting regulatory submissions, maintaining product compliance, and providing strategic regulatory guidance to cross-functional teams **across the China, Taiwan, and Hong Kong markets** .

This remote based position must be within Pacific Standard Time (PST) or Mountain Standard Time (MST) zones to ensure effective collaboration with cross-functional teams.

Job 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.

Educations and Experience 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.

Knowledge and Skills required:

+ 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 qualifications:

+ Advanced degree (Master's or Ph.D.) preferred not required.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit  https://bd.com/careers

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA CA - Irvine Laguna Canyon

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (https://jobs.bd.com/en/our-commitment-to-you) .

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$80,600.00 - $133,000.00 USD Annual

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.