Regulatory Affairs Specialist - NMPACFDA

Primary Function of Position

This RA Specialist will play a key role in managing China RA regulatory intelligence working closely with the incountry RA team to facilitate China regulation and standard assessment.  This position will also collaborate with the local RA team the Product Localization Engineering (PLE) and other crossfunctional supporting teams to ensure the companys regulatory affairs activities are conducted in accordance with company policies and in compliance with the latest relevant regulations and standards. The goal is to maintain regulatory compliance across all relevant aspects of the product lifecycle for China and Hong Kong.  Additional responsibilities include regulatory operation activities to support the Approved Product List (APL) process and product shipping block (RA Block) and release processes.  The RA Specialist will also provide crossfunctional support and manage assigned tasks pertaining to premarket applications and/or postmarket regulatory compliances.

Essential Job Duties

• Regulatory Intelligence Coordination
  • Serve as the Point of Contact (PoC) for Regulatory Intelligence focusing on Regulations and Standards Assessment (RSA) for China RAQA department. 
  • Collaborate with the incountry RA team to monitor maintain and communicate updates on  China Regulations & Standards applicable to ISI products.
  • Work with the ISI RSM team to update standards and regulations in Trackwise engaging with ISI SMEs for RSA completion and implementation as needed.
  • Conduct gap assessment on China regulatory changes to support strategic decisionmaking.
  • Maintain a knowledge base of regulatory affairs guidelines in China and Hong Kong providing input on updated regulations and standards as needed.
• Regulatory submissions and GRA (Global Regulatory Assessment)
  • Coordinate and prepare regulatory filing/submission documents and work with incountry RA team for submissions to regulatory authorities in China & Hong Kong.
  • Provide regulatory guidance on China and Hong Kong regulatory requirements for new product development and product change projects ensure compliance with submission deliverables.
  • Maintain regulatory clearances and approvals including necessary filings archival and communications.
  • Conduct global regulatory assessment (GRA) for Hong Kong in partnership with the incountry RA team and prepare the associated change notifications and registrations to support supply continuity.
• Regulatory Operations
  • Support the postmarket team in preparing the China Periodic Safety Update Reports (PSUR) and annual inspection report.
  • Support the Approved Product List (APL) process.
  • Assist in product shipping block (RA Block) and release processes. 
  • Develop and maintain departmental procedures and database contributing to continuous improvement initiatives as needed.
  • Coordinate recall or market withdrawal activities as needed.

Qualifications :

Required Skills and Experience

• Minimum 3 years RA experience is required.  
• Demonstrated understanding of NMPA medical device regulatory requirements China GB/YY standards Hong Kong MDD regulatory requirements as well as fundamental US FDA requirements posed on medical device.
• Experience with new product development projects for complex products.
• Proven verbal and written communication skills proven ability to translate technical documentation into effective regulatory submissions.
• Good interpersonal skills and able to work well with cross functional teams.
• Solid project management skills experience of working (as a leader or coleader or project manager) crossfunctionally/regionally to support strategy development drive planning and execute to aggressive goals
• Keen on delivering quality results and introducing best practices.
• Highly proficient in Microsoft Word Excel and Project applications

Required Education and Training

• Education: B.S./B.E. or higher in life science biomedical engineering or related filed.
• Advanced degree preferred.

Preferred Skills and Experience

• Minimum 2 years working experiences supporting international submissions preferred
• Previous China/Hong Kong regulatory affairs experience a major plus.
• Crosscultural (China/Hong Kong) RA project related a plus.
• SaMD and SiMD knowledge a plus.
• RAC (regulatory affairs certified) desirable.
• Ability to speak and write in Chinese is a plus.
• Knowledge of SAP Agile or similar business systems desired.

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Remote Work :

No

Employment Type :

Fulltime