Miltenyi Biotec continues to grow. Our corporate culture encourages you to shape your own ideas and to create a new dynamic. Welcome to a team that thrives on innovation.

RA Manager

DUTIES AND RESPONSIBLITIES:

Propose / develop, implement, review and update regulatory affairs strategy. Initiate activities in cope with the long-term and short-term RA strategy. Oversee the progress to ensure product registration operations to be excellent.

  • Review product registration strategy and action plan. Timely make recommendations to adjust the strategy to top management team.
  • Coordinates with corporate to set up registration plan based on the business needs, ensuring the business compliance with national regulations.
  • Familiar with NMPA regulations, process, document review principle and technical requirements. Review registration dossier as internal examiner and guide the project team members to prepare registration documents.
  • Prepare regulatory submissions and obtain regulatory permits, including import/export clearance in a timely manner
  • Get Corporate RA people understand China RA policy, get aligned and work closely with them.
  • Interact with and build rapport with regulatory agencies and notified bodies as required to perform effective and fast track approval of product registrations.
  • Monitor the regulation development and regulatory trend in China, report the impact to the company.
  • Organize and deliver regulatory education and dissemination of regulation information to the organization.
  • Periodically review registration progress and issues with medical staff and other internal groups like marketing, BD, Commercial team.

REQUIREMENTS:

  • Bachelor degree or above in clinical laboratory, health/life science discipline or the equivalent knowledge and experience;
  • Minimum 5 years of professional experience in a regulated environment; solid relationship with authority and office;
  • Solid knowledge and experience in RA of medical device (pharmaceutical preferred), ISO knowledge is preferred;
  • Fluent in English and Microsoft office skills.

Your Contact



Progress prospers with inspiration and curiosity. For 30 years Miltenyi Biotec has been developing products and services that are used in basic research, translational research and cell therapy. Today we are a team of more than 2,500 scientists, physicians, engineers, marketers and numerous other specialists. At Miltenyi Biotec, innovative ideas are being turned into cutting edge products. Together, we are passionate about driving biomedical progress towards curing severe diseases.

Come break boundaries
with us today.

Miltenyi Biotec Technology & Trading (Shanghai) Co., Ltd.
Rooms 2303 and 2309
No. 319, Xianxia Road
Changning District
200051 Shanghai, P.R. China
miltenyihr@miltenyibiotec.com.cn