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Regulatory Affairs Specialist

3 months ago

Bedford, United States Actalent Full time
**Language fluency required: English & Chinese essential**
Position Summary:
The Regulatory Specialist will be responsible for China NMPA and Japan PMDA registration and renewal activities. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain regulatory compliance.
Responsibilities:
Responsible to participate on design and risk management teams as the regulatory representative and provide guidance on China NMPA and Japan PMDA requirements, including:
  • Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input
  • Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output
  • Prepare new product registration packages for China NMPA and Japan PMDA
  • Assist with product renewal packages to maintain country registrations
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
  • Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current scientific and regulatory standards
  • Responsible for maintenance of Regulatory Database in SAP
  • Educate and train personnel on international country registration and labeling requirements to ensure that during product development, their requirements are understood and incorporated
  • Other assignments related to RA/QA to support company requirements and priorities
Additional Skills & Qualifications:
  • Bachelor's degree in engineering or science, or advanced degree
  • 3-4 years' experience in the medical device industry (in-vitro diagnostics a plus) or equivalent experience
  • Experience in the preparation of technical submission to obtain NMPA and /or PMDA regulatory approval
  • Demonstrated understanding of NMPA Decree 680 along with its lower-level regulations pertaining to the QMS and other general product registration matters, as well as CFR 21 820/ISO 13485 requirements
  • RAC certification is a plus
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.