Elekta is looking for a Regulatory Affairs Engineer

Elekta is proud to be the leading innovator of equipment and software used to improve, prolong and save the lives of people with cancer and brain disorders. Our advanced, effective solutions are created in collaboration with customers, and more than 6,000 hospitals worldwide rely on Elekta technology. Our treatment solutions and oncology informatics portfolios are designed to enhance the delivery of radiation therapy, radiosurgery and brachytherapy, and to drive cost efficiency in clinical workflows. Elekta employs 3,800 people around the world. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm.

Elekta is looking for a Regulatory Affairs Engineer. The Company Elekta offers a global environment where entrepreneurial thinking is highly valued. You will be a part of a motivated and self-propelled team where you can influence the development of the company as well as your own career.

If you’re as passionate about humanity and innovation as we are then maybe we should meet.

The Role

Regulatory Affairs is the decision authority on regulatory matters across the organization. The function proposes and implements company policy on: compliance, labelling review, product registrations, standardization, regulatory strategy, post-market surveillance, radiation safety, etc.

The Regulatory Affairs Engineer supports the Elekta organization globally in the delivery of its products in a regulated environment. You will work closely with business areas including manufacturing and supply chain, research and development and engineering. You will liaison with regulatory authorities. This is a high impact role in a mid-size company with short communication lines that works in a fast-paced dynamic environment and makes a meaningful contribution to Elekta’s business. The position is placed in Stockholm.

Requirements

At Elekta we are proud to say that we live by our values:

• We work as one team: that means we’re looking for a team player – and the team is 3,800 strong. Of course, you won’t be interacting with all your colleagues, but you’ll be able to carry the ball within your group.
• We do what we say: our customers need to trust you as much as they trust our solutions – there is no room for empty promises in cancer care.
• We keep thinking forward: Elekta’s history and success has been built on people who turn today’s challenges into tomorrow’s solutions. We hope you’re this type of person.

Your key responsibilities are:

• Support the implementation of the new European Medical Device regulation
• Provide guidance on product regulation and translate into meaningful business requirements
• Gain market access for our regulated products including submissions
• Communicate with regional and business teams and prepare responses on all governing agency actions
• Review promotional labelling
• Represent regulatory affairs in new product development as well as maintenance projects
• Participate in product release process
• Participate in regulatory process improvements work

Is this you?

To be successful in this role you have experience in Regulatory Affairs. You have gained experienced at an industrial company working with manufacturing or product development, preferably in the MedTech or Medical devices industry. We value experience from working with quality assurance, compliance issues and experience from working with internal and external audits. We also value your ability to apply your expertise to a variety of problems and being able to find smart solutions within the regulatory area. Your English skills are excellent, both orally and written. You have a Bachelor of Science (Mechanical, Electrical, Industrial Engineering, etc.) or equivalent degree. We are looking for a Regulatory Affairs professional, preferably with experience in regulatory processes, product development and/or submissions strategies.

In this recruitment, your personal attributes will be of great importance! We are looking for someone who has great communication skills and can work unsupervised under own initiative. We also see you as an analytic and flexible person in your way of working. Excellent problem-solving skills are also highly valued.

Search: regulatory affairs, RA engineer, product management, MedTech, quality assurance, compliance work