Risk Management Professional

1 day ago


Stockholm, Stockholm, Sweden SHL Group Full time

About the Company:

SHL Medical Overview

SHL Medical is a world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems. Our customers include top pharmaceutical and biotech companies from around the globe.

Job Description:

The Risk Manager is responsible for reviewing risk management related topics within Design and Development Projects. The ideal candidate will have experience working with regulations and ISO standards, specifically EN ISO 14971:2019 and EN ISO 13485:2016.

Main Responsibilities:

  1. Support the project team to conduct the risk management activities and establish a risk management file.
  2. Establish documents and approve established documents and records as Risk Manager.
  3. Participate in design reviews as Risk Manager.
  4. Be responsible for customer communication related to risk management activities in the customer design and development project.
  5. Participate in CAPAs and change controls as Risk Manager.

Requirements:

  1. 3-5+ years of relevant work experience.
  2. Experience working with regulations and ISO standards.
  3. Engineering degree, such as mechanical engineering.

We Offer:

  • A collaborative and communicative mindset.
  • Fluency in Swedish.


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