Regulatory Affairs Specialist

We are looking for a Regulatory Affairs Specialist to join our head office in Malmö! We are a dynamic department supporting many areas of the Arjo business, you will interact with many functions and people in our regional offices around the world. Some of the key activities and responsibilities we would like you to be involved with are:
• Compiling European Medical Device Regulation (EU MDR) Technical Files. A key activity to ensure successful Notified Body reviews. You will liaise with internal and external stakeholder, perform change and gap assessments on Technical Files/Design Dossiers
• Representing our Regulatory Affairs department in project meetings with internal stake holders and providing regulatory guidance to ensure we adhere with global regulatory requirements
• Performing reviews of our existing Technical Files according to new EU MDR
• Working with your regulatory colleagues who will assist you to prepare product registration documentation to achieve manufacturing or product licences for our extensive range of medical device products
• Performing impact assessments on aspects of product design, engineering changes and management system planning. We would like you to review and assess changes to industry standards and regulations and prepare action plans to mitigate compliance and business risks.
* Act as member of Person Responsible for Regulatory Compliance (PRRC) Group


The skills you will need
• Bachelor degree is the minimum requirement with a major in a scientific discipline
• Regulatory experience in the medical device industry and experience in Quality Assurance / Regulatory Assurance would be desirable
• Ability to work well on cross-functional teams in order to supporting product design and development projects
• Must be able to render clear and accurate judgments.
• Computer knowledge in Microsoft Word, Excel, Access, etc
• Excellent written and verbal communication skills
• Intercultural skills
• Team building and networking skills
• Strategic thinking, pragmatic and ability to make decisions
• Ability to work independently in a well-structured and systematic manner


What we will offer in return
You will support our vision to be the most trusted partner in driving healthier outcomes for people facing mobility challenges. In return, we recognize and value our global employees. You will have our full support, training and opportunities for professional development.


Why diversity matters to us
At Arjo, we believe in the power of diversity. We strongly encourage applicants from all parts of society, which means building a more diverse, equitable, inclusive and engaging environment – not only in the workplace, but also within the communities that we serve, work in and live in. We achieve this through a culture and mindset that values the uniqueness of all our people.


We look forward to receiving your application! Applications will be reviewed and interviews scheduled continuously as applications are received. Please apply no later than February 24.