Hillrom is a global medical technology leader whose 10,000 employees in over 100 countries have a single purpose: enhancing outcomes for patients and their caregivers by Advancing Connected Care™. Around the world, the Hillrom´s innovations touch over 7 million patients each day through connected smart beds, patient lifts, patient assessment and monitoring technologies, caregiver collaboration tools, respiratory care devices, advanced operating room equipment and more, delivering actionable, real-time insights at the point of care. Hillrom was founded in 1915 and today has an annual turnover of 2,8 billion dollars with 150 employees in Sweden. To find out more, visit, www.hillrom.com
Do you want to be part of a truly great team and a global organization with good values and a clear purpose?
Hillrom is now looking for an Engineer in Regulatory affairs (RA). The Hillrom Global Regulatory Affairs Mission is to be a world class regulatory organization through expertise and timely regulatory intelligence dissemination, cross-functional collaboration, and alignment with Hillrom business initiatives. Additionally, Hillrom offer best-in-class regulatory support via proactive regulatory engagement, efficient operational infrastructure, involvement with global regulatory organizations, and talent development, thereby enabling a high level of regulatory compliance and growth in their strategic markets.
The main responsibilities of the RA Engineer are:
- To work with technical documentation (and sometimes be the document owner) and make sure that Hillrom´s products upholds central, safety and performance requirements. Provide technical review of product to ensure alignment with national and international codes and standards.
- Work with the global registration process by submitting specific documentation to regional regulatory personnel to support global regulatory submissions, allowing marketing and sales of Hillrom products. Local site contact with Swedish authority for licensing, Swedish country regulatory notarizations, Free Sale Certificates.
- Work with local engineering teams to provide regulatory input to product lifecycle planning and provide global Standards expertise.
- Review regulatory Intelligence databases to identify emerging issues, potential impact on products
- General on-site Audit support: Annual Notified Body, quarterly service audits, corporate audits.
- Advise local and global teams on new or updated global regulations.
- Resolve compliance issues.
Furthermore, Hillrom work according to LEAN- principles. The organization focus on continuous improvements and a problem-solving culture. “Hillrom welcome problems, because when we identify problems; we can improve”.
Hillrom believe the right candidate to have a technical background and experience of working in an industry or organization with a high presence of regulations and standardizations preferably in ISO / IEC and a quality management system. Preferably, the candidate has experience of working globally and having multiple contacts with authorities and other stakeholders.
- Have a Bachelor of science in Engineering in a technical discipline.
- Experience as an engineer.
- Have a demonstrated ability to assess and understand regulatory requirements and able to explain this to a third person.
- Speak and write Swedish and English fluently.
You will work at the plant in Alvik outside Lulea where you will report to the Manager of Codes and standard who is stationed in Batesville, US, and you will be a part of Hillrom’s global RA- organization.
Who you are:
You are a problem-solver and like to dive deep in technical or regulatory topics. You are analytical, persevering and do not give up until you find the answer. You are self-confident and trust your own knowledge and abilities. To work self-sufficient is not a problem and you drive your processes forward in an efficient manner with high quality on the end-result. You plan, do, and act with the focus on People, Quality, Delivery and Cost.
You are comfortable collaborating with a cross functional team of technical and non-technical team members. You thrive in a global environment and have no problem to connect with people and different cultures. You are a team player and are communicative both in speech and writing.
Hillrom offer you a challenge and possibility to personal development in a leading worldwide company in the medical technology industry.
If you have any questions about the position please contact Executive Search Consultant at Cesab Rekrytering, Tomas Blomster, email@example.com, +46 766-365 760