RA Engineer to Hillrom LuleåYrke: Civilingenjör, medicinsk teknik
Arbetsgivare: Liko AB
Arbetets ort: Luleå, Norrbottens län
Senaste ansökningsdatum: 2021-05-16
Do you want to be part of a truly great team and a global organization with good values and a clear purpose? If yes, then you need to read this! We are now looking for an Engineer in Regulatory affairs (RA). You will work at our plant in Alvik, Lulea and you report to the Manager of Codes and standard who is stationed in Batesville, US, and you will be a part of our global RA- organization.
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.
We 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 our strategic markets.
About the position
The main responsibilities of the RA Engineer are:
- To work with technical documentation (and sometimes be the document owner) and make sure that our 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.
We work according LEAN- principles and our OMS (Operative Management System). We focus on continuous improvements and have a problem-solving culture. We welcome problems, because when we identify problems; we can improve.
What is your background
You have a technical background and have 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. You have experience of working globally and having multiple contacts with authorities and other stakeholders.
- Have a Bachelor of science in Engineering in a technical discipline.
- Have 10 years of 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.
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.
We offer you a challenge and possibility to personal development in a leading worldwide company in the medical technology industry.
Last day to send in your application is 16th of May. Your application must be in English and include a resumé and cover letter. You apply via Careers | Hillrom or "Ansök här" in this ad.
If you have any questions about the position please contact Linnea Larsson, HR Business Partner, firstname.lastname@example.org.