Senior Regulatory Affairs Engineer and interim Team Lead
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 can influence the development of the company as well as your own career. Elekta is looking for a senior Regulatory Affairs Engineer with team lead skills.
The function 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.
Regulatory Affairs is now looking for a senior Regulatory Affairs Engineer. The senior 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 like manufacturing, engineering, supply chain, and sales. 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.
You will be employed as a senior Regulatory Affairs Engineer, but you will have a team lead responsibility for a group of three Regulatory Affairs engineers during a maternity leave of 1 year. The position is placed in Stockholm and you will report to the Regulatory Affairs director EMEA.
Your key responsibilities are:
- Coordinate and support the day to day work in the Swedish Regulatory Affairs group
- 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 7 or more years’ experience in Regulatory Affairs and experience from a team lead role. 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, can coach 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.
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.
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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.