Make an impact with Laerdal!

Do you want to play a key role in bringing and keeping medical devices on the market?
Make a difference with Laerdal where immersive technology transforms healthcare quality and education across the globe. With over 2,200 colleagues, join a team where collaboration and engagement are prioritized in helping save one million more lives, every year, by 2030.

About the role

As a Regulatory Affairs Specialist you will support medical device development teams to obtain and maintain medical device approvals in the Laerdal markets. You will be responsible for identifying applicable requirements for investigational devices and medical devices, including software as a medical device.

Key responsibilities include:

• Support medical device development teams in obtaining and maintaining medical device approvals.

• Develop regulatory strategies for clinical investigations.

• Provide regulatory support regarding software as a medical device (SaMD) and software in a medical device (SiMD).

• Assess and report Vigilance cases to Competent Authorities.

• Maintain medical device databases and keep establishment registrations up to date.

**What we are looking for:**We are looking for a Regulatory Affairs Specialist with strong analytical and problem-solving skills to strengthen our Corporate Quality (Q) and Regulatory (R) team. The Corporate Q&R team is a support function organized as a part of the CEO’s staff, and is based in Stavanger, Norway.

Preferred qualifications:

• Degree in technology, engineering or natural science.

• Experience with medical devices in the area of Regulatory Affairs or Study Start-up, with a basic understanding of regulations and standards applicable to medical devices.

• Well organized with attention to detail and have demonstrated an ability to be proactive and meet deadlines.

• Engage in collaborative problem solving with cross-functional teams and have strong interpersonal skills and professionalism.

• Good technical understanding and work independently to obtain new knowledge.

What we offer

• A meaningful role contributing to a life-saving mission

• A creative, inclusive, and international work environment

• Great opportunities for professional and personal development

• A company driven by innovation and forward-thinking technology

• Competitive salary, pension scheme, and insurance

• A generous welfare program including discounted public transport, indoor bicycle garage, wardrobe with towel service, social and sports groups, company cabins, and more

For questions about the position, please contact Claudia Pajares Ibáñez, Regulatory Affairs Manager -- Medical Device at Claudia.Pajares.Ibanez@laerdal.com.

Ready to apply?
Please register your application by 17.03.26.

Please note that we use Semac background checks in our recruitment process.

We look forward to hearing from you!