Risk Manager
Stockholm, Sweden
About the company
SHL Medical is a world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.
Job Overview
The Risk Manger is responsible for reviewing risk management related topics within Design and Development Projects and participates in the development, implementation and administration of SHL’s risk management processes. The Risk Manager will carry out activities in accordance with SHL’s QMS, following Quality Policy, Standard Operating Procedures and Work Instructions that apply to the position.
Main Responsibilities
To support the project team to conduct the risk management activities, to establish a risk management file.
To establish documents and approve established documents and records as Risk Manager.
To support the project team to determine acceptance criteria for each DIR item (Design Input Requirements) based on results from risk assessment.
To participate in design reviews as Risk Manager.
To be responsible for customer communication related to risk management activities in the customer design and development project.
To participate in the implementation and administration of SHL’s risk management process in the Sweden office.
To participate in the development of SHL’s risk management process, together with other relevant functions.
To provide training in SHL’s risk management process for Sweden office staff.
To participate in CAPAs as Risk Manager.
To participate in change controls related to design and/or product production as Risk Manager.
Skills and Qualifications
Minimum Requirements:
Engineering degree, such as mechanical engineering.
Fluency in English, speech and writing.
Experience working with regulations and ISO standards, specifically EN ISO 14971:2019 and EN ISO 13485:2016.
Experience working with Risk Management, Quality Assurance, and/or Regulatory Affairs.
3-5+ years of relevant work experience.
Preferred Requirements:
Experience from working with risk assessments for medical devices.
Fluency in Swedish.
A collaborative and communicative mindset.
Experience from working in a global, matrix organisation.
Experience from working with pharmaceutical companies.
Experience from establishing, reviewing and approving quality documentation.
We Offer
A company culture with Focus on Customer, Operate with Ethics and Integrity, Drive Simplicity, Learn and Improve, & Deliver Together.
Modern working environment with state-of-the-art facilities and technologies.
Challenging assignments in a fast-growing and innovative industry.
Position in a dynamic, international team of highly skilled professionals.
Various opportunities for personal and professional development within a global organization.
Flexible hours and hybrid working policy.
Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents.
For more information on SHL Medical, please visit: shl-medical.com
Please note: We do not accept applications from recruitment agencies for this role.
