About this role
<p style="margin:0.0cm;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:'Segoe UI', sans-serif;color:black">SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.</span></p> <p style="margin:0.0cm;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:9.0pt;font-family:'Segoe UI', sans-serif">Job Overview</span></strong></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;font-family:'Segoe UI', sans-serif;color:black">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.</span></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:9.0pt;font-family:'Segoe UI', sans-serif">Main Responsibilities</span></strong></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">To participate in the implementation and administration of SHL’s risk management process in the Sweden office.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Participate in the implementation and administration of SHL’s Risk Management process within the Sweden office.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Contribute to the continuous development and improvement of SHL’s Risk Management processes in collaboration with relevant cross-functional teams.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Provide training and guidance on SHL’s Risk Management processes to employees within the Sweden organization.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Participate in CAPA activities in the role of Risk Manager.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Perform additional tasks and responsibilities related to the position, as required.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Supporting project teams in establishing Risk Management Plans.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Supporting the definition of acceptance criteria for Design Input Requirements (DIRs) based on risk assessment outcomes.</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Participating in design reviews in the role of Risk Manager.</span></li> </ul> <p style="margin:0.0cm;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:9.0pt;font-family:'Segoe UI', sans-serif">Minimum requirements</span></strong><span style="font-size:9.0pt;font-family:'Segoe UI', sans-serif;color:black"> </span></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;color:black"></span><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Bachelor’s degree in Life Science or Engineering</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Minimum 3 years of relevant professional experience</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Experience within Risk Management, Quality Assurance, and/or Regulatory Affairs in a regulated industry</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Experience interpreting and applying standards such as EN ISO 14971:2019 and EN ISO 13485:2016</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Experience establishing, reviewing, and approving quality documentation</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="color:black">E</span><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">xperience of collaborating with pharmaceutical companies and external stakeholders</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Fluent in written and spoken English. </span></li> </ul> <p style="margin:0.0cm;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Preferred Qualifications</span></strong></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Experience working within the Medical Device or Combination Product industry</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Experience participating in product development projects and Design Control activities</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Knowledge of CAPA, change control, and non-conformance management processes</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.4px;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif;text-indent:0.4px"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Fluent in written and spoken in Swedish </span></li> </ul> <p style="margin:0.0cm;text-align:justify;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:9.0pt;font-family:'Segoe UI', sans-serif">We Offer</span></strong></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="text-align:justify;margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Challenging assignments in a fast-growing and innovative industry. </span></li> <li style="text-align:justify;margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">An exciting opportunity in a fast-growing international medical technology company.</span></li> <li style="text-align:justify;margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">A modern working environment with multicultural and dynamic teams.</span></li> <li style="text-align:justify;margin:0.0cm 0.0cm 8.0pt 0.0px;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">A centrally located office in Zug, very close to the train station.</span></li> </ul> <p style="margin:0.0cm;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department. </span></p> <p style="margin:0.0cm;text-align:justify;background-color:white;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">For more information on SHL Medical, please visit: shl-medical.com/careers </span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Calibri, sans-serif"><strong><span style="font-size:9.0pt;line-height:107%;font-family:'Segoe UI', sans-serif;color:black">Please note: We do not accept applications from recruitment agencies for this position.</span></strong></p>