We are looking for an innovative candidate to be a key contributor as Sr. Product Technical Services & Regulatory Engineer. In this role, you will represent and help development Align Sichuan Medical Equipment Company’s design history file (DHF), device master record (DMR) and risk management file for medical device products placed in the market for China. You will be providing technical engineering, regulatory and quality direction to support the local team and also represent the product design during inquiries, submissions and audits. This candidate will work closely with cross functional engineering and product teams (located in California, USA) to write, edit, review and finalize technical documents and specifications required for global regulatory submissions of medical device products which includes but not limited to testing and documents for pre-submissions, verification and validation protocols and reports. Knowledge of China medical device documentation regulatory requirements and previous experience with the National Medical Product Administration desired.
In this role, you will…
- to local team
- Provide technical direction and support to R&D cross functional teams, regarding design control process of medical devices for China, e.g. verification and validation of Invisalign System
- Prepare technical guidance/documentations for internal customers to meet various regulatory and quality requirements
- Respond to questions and concerns from internal customers on various issues related to regulatory submissions and technical aspects of products by benching testing, data analysis and documentation
- Perform and assist in risk management and root cause analysis for customer complaints
- Perform technology reviews with regional regulatory teams on medical devices with compliance to the country regulations
- Evaluate, review feasibility and support requested claim’s substantiation
In this role, you’ll need …
- Advanced written and spoken English is required as this role will be required to collaborate with Global Product & Engineering Management team.
- Ability to work with minimal supervision, completes tasks as directed
- Exceptional communication and documentation skills, with ability to work cross-functionally with a diverse group of people and functions to drive to a timely and high quality solution
- Strong presentation skills - proficient in PowerPoint, Visio, Word and Excel
- Proven technical writing skills and expertise
- Strong organization and project management skills
- Ability to prioritize the diverse set of tasks required in the role
- Desire and willingness to development clinical and technical understanding of Invisalign products and orthodontics
EDUCATION and/or EXPERIENCE
- or above in science, engineering discipline, health or regulatory sciences
- 8+ years of experience in medical device/pharmaceutical industry, familiar with medical device regulations and product development for medical devices.
- Engineering experience and Technical Writing desired.
