SHL RA Standards and Regulations Specialist

Job Description

  1. Tracks and updates all policies, regulations and standards of pre-market registration and post-market supervision, and timely transmitting the relevant information to China team and HQ.
  2. Identifies standardization organizations and business relevant technical committees, establish connection and relationship with them.
  3. Establishes good relationship with industry associations and key partners.
  4. Follows up with relevant associations and standardization organizations, and timely feedback the opinions and suggestions on policies, regulations and standards to corresponding authorities.
  5. Safeguards awareness and observation of technical market access conditions such as regulations, conformity assessment and certification requirements. Responsible for active observation of relevant legislation and for providing that information into the knowledge-sharing platform in order to foster legal compliance according to the relevant technical regulation.

- Above 3-year experience in medical device regulatory affairs or standardization management

- Basic skill in full understanding of regulations and medical device standards

- Excellent skill in problem solving and cooperation

- Highly verbal and written communication skills in English as well as Chinese

- Able to work on international level/in an international environment

    Organization: Siemens Healthineers

    Company: Siemens Healthineers Ltd.

    Experience Level: Experienced Professional

    Job Type: Full-time

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