Elekta is loooking for a Regulatory Affairs Engineer
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 European team where you have the ability to influence the development of the company as well as your own career.
Regulatory Affairs is the decision authority on regulatory, environmental and export control matters across the organization. The function proposes and implements company policy on regulatory issues such as: compliance, labelling review, product registrations, standardization, regulatory strategy, post market surveillance, radiation safety, etc.
The function Regulatory Affairs is now looking for a Regulatory Affairs Engineer. The Regulatory Affairs Engineer works as part of the European team to support 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 that works in a fast paced dynamic environment and makes a meaningful contribution to Elekta’s business.
The position is placed in Stockholm.
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 in product maintenance
- Participate in product release process
- Participate in regulatory process improvements work
Är det här du?
To be successful in this role we would prefer solid 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 and quality area. Your English skills are excellent, both orally and written. You have a Bachelor of Science (Mechanical, Electrical, Industrial Engineering, etc.) or equivalent engineering degree. We are looking for a Regulatory Affairs professional, preferably with experience in product development and submissions strategies, or equivalent.
In this recruitment, your personal attributes will be of great importance! We are looking for someone who has great communication skills and has the ability to 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.
Do you want to know more?
In this process Elekta is working with Level Recruitment. To apply, please click at the apply button. If you have any questions please contact recruitment consultant Louisa Torstensson at 08-120 50 423.
Search: regulatory affairs, RA engineer, product management, MedTech, quality assurance, compliance work
Om Elekta Instrument AB
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. The company develops sophisticated, state-of-the-art tools and treatment planning systems for radiation therapy, radiosurgery and brachytherapy, as well as workflow enhancing software systems across the spectrum of cancer care. Stretching the boundaries of science and technology, providing intelligent and resource-efficient solutions that offer confidence to both health care providers and patients, Elekta aims to improve, prolong and even save patient lives.
Today, Elekta solutions in oncology and neurosurgery are used in over 6,000 hospitals worldwide. Elekta employs around 3,800 employees globally. The corporate headquarters is located in Stockholm, Sweden, and the company is listed on the Nordic Exchange under the ticker STO:EKTAB. Website: www.elekta.com.
08-120 50 423
Tjänstens omfattning: Heltid