Smith+NephewChina Regulatory Affairs Specialist
Smith+Nephew is hiring a China Regulatory Affairs Specialist. Level rates it ; you can apply on Smith+Nephew.
Level's read on this job
- On Level's scale, this role is Little AI ●○○○: aI is not part of the work.
- The posting mentions regulatory affairs, quality assurance and compliance among its tools and skills.
- Level classes it as a mid-level role.
- Smith+Nephew has 346 other open roles on Level.
- Posted within the past week.
AI in this role
China Regulatory Affairs Specialist managing product registrations, compliance, and quality assurance activities.
Regulatory Affairs Operations
- Prepare, compile, review, and submit regulatory documentation for product registrations, renewals, amendments, notifications, and other lifecycle management activities in Hong Kong and Macau.
- Coordinate with internal stakeholders to obtain required technical, quality, clinical, and regulatory documentation to support submissions.
- Maintain regulatory licenses, approvals, certificates, and product registration databases to ensure continued compliance.
- Monitor approval status and follow up on regulatory submissions to support timely market access.
- Support regulatory assessments for product changes, labeling updates, manufacturing changes, and other regulatory impact evaluations.
Quality Assurance Activities
- Support complaint handling activities in accordance with company procedures and applicable regulatory requirements.
- Assist with complaint documentation, investigation follow-up, trending, and record maintenance.
- Support post-market surveillance and vigilance activities where applicable.
- Maintain quality records and documentation in compliance with Quality Management System requirements.
- Assist with field actions, recalls, advisory notices, and other quality-related activities as required.
Regional Regulatory Support
- Prepare and submit regulatory dossiers for assigned international markets.
- Coordinate with distributors, authorized representatives, and internal stakeholders to support registration and maintenance activities.
- Support responses to regulatory authority questions and requests for additional information.
- Maintain regulatory records and approval status tracking for assigned markets.
- Participate in new product launch and market expansion projects from a regulatory perspective.
Stay connected by joining our Talent Community.
We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.
Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.
Explore our website and learn more about our mission, our team, and the opportunities we offer.
How we rate this
China Regulatory Affairs Specialist at Smith+Nephew rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
Prepare for this job
Built from this posting and from similar jobs on Level.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where regulatory affairs was part of your work. What did you do?
- Tell me about a project where quality assurance was part of your work. What did you do?
- Tell me about a project where compliance was part of your work. What did you do?
- Tell me about a project where documentation was part of your work. What did you do?
Adapt your resume
- List these exact terms on your resume: Regulatory Affairs, Quality Assurance, Compliance, and Documentation. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.
Get your CV reviewed before you apply
Send your CV and the role you want next. Your review arrives by email within 3 days.
Get new AI jobs by email
One email a week, each job rated for how much AI is in the work. No recruiter spam, unsubscribe in one click.
Free.
Similar roles
Other roles that involve little AI, at other companies.
What kind of AI work fits you?
Answer 12 practical questions in about three minutes. Get a simple profile, the work it points to, and live roles to explore next.
Find my next step