Junior Risk Manager

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.

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.

Main Responsibilities

To participate in the implementation and administration of SHL's risk management process in the Sweden office.

Participate in the implementation and administration of SHL's Risk Management process within the Sweden office.

Contribute to the continuous development and improvement of SHL's Risk Management processes in collaboration with relevant cross-functional teams.

Provide training and guidance on SHL's Risk Management processes to employees within the Sweden organization.

Participate in CAPA activities in the role of Risk Manager.

Perform additional tasks and responsibilities related to the position, as required.

Supporting project teams in establishing Risk Management Plans.

Supporting the definition of acceptance criteria for Design Input Requirements (DIRs) based on risk assessment outcomes.

Participating in design reviews in the role of Risk Manager.

Minimum requirements

Bachelor's degree in Life Science or Engineering

Minimum 3 years of relevant professional experience

Experience within Risk Management, Quality Assurance, and/or Regulatory Affairs in a regulated industry

Experience interpreting and applying standards such as EN ISO 14971:2019 and EN ISO 13485:2016

Experience establishing, reviewing, and approving quality documentation

Experience of collaborating with pharmaceutical companies and external stakeholders

Fluent in written and spoken English.

Preferred Qualifications

Experience working within the Medical Device or Combination Product industry

Experience participating in product development projects and Design Control activities

Knowledge of CAPA, change control, and non-conformance management processes

Fluent in written and spoken in Swedish

We Offer

Challenging assignments in a fast-growing and innovative industry.

An exciting opportunity in a fast-growing international medical technology company.

A modern working environment with multicultural and dynamic teams.

A centrally located office in Zug, very close to the train station.

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.

Please note: We do not accept applications from recruitment agencies for this position.