Regulatory Affairs Specialist

Veenendaal, Utrecht, Netherlands · Elekta · L639 expand job description ↓

Description

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. The 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 3,600 people around the world. Headquartered in Stockholm, Sweden, Elekta is listed on NASDAQ Stockholm.

Elekta is looking for a Regulatory Affairs Specialist! 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 have the ability to influence the development of the company as well as your own career.

If you’re as passionate about humanity and innovation as Elekta is then we should meet.


Purpose of the role
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: trade compliance, labeling review, product registrations, standardization, regulatory strategy, radiation safety etc.



Responsibilities
Your key responsibilities will be the following:

  • Provide guidance on product regulation (class I to III) 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 labeling;
  • Represent regulatory affairs in new product development as well as maintenance projects;
  • Participate in product release process;
  • Participate in regulatory process improvements work in Europe.

  • Department & supervisor
    The Regulatory Affairs Specialist reports to the Director Regulatory Affairs EMEA, Egbert Hovenkamp. You will work in the Dutch regulatory team with Regulatory Affairs Specialist, Engineers and Associate (4 FTE), all part of Elekta’s growing European team divided over 4 countries. You will work closely with these other teams.


    The Regulatory Affairs Specialist 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 Veenendaal, centrally located in The Netherlands and easily accessible to public transport and highway.

    Requirements

    Elekta is proud to live by their values:


  • At Elekta they work as one team: that means Elekta is looking for a team player – and the team is 3,600 strong. Of course, you won’t be interacting with all your colleagues, but you’ll be able to carry the ball within your group.
  • At Elekta they do what they say: the customers need to trust you as much as they trust Elekta’s solutions – there is no room for empty promises in cancer care.
  • Elekta is 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.
  • Besides living by Elekta’s values, we think you have earlier experience from:



  • A Master of Science degree (Mechanical, Electrical, Industrial Engineering, Software, etc.) or equivalent engineering degree;
  • At least 3 – 7 years’ experience in Regulatory Affairs;
  • Experienced at an industrial company working with manufacturing or product development, preferably in the MedTech industry;
  • Preferably with experience from working with quality assurance, compliance issues and experience from working with internal and external audits;
  • Preferably with experience in particular product submissions strategies and handling, or equivalent;
  • Ability to apply your expertise to a variety of problems and being able to find smart solutions within the regulatory and quality area;
  • Excellent English communication skills, both orally and written;
  • Proficient in Microsoft Office applications;
  • Proficient with various software applications (ERP, CLM, EDMS, etc.);
  • Ability to work unsupervised under own initiative;
  • Ability to interpret authority regulations;
  • Ability or willing to mentor and lead problem solving;
  • Appreciate compliance work;
  • Flexible, analytical, and excellent problem solving skills.
  • Benefits

  • Annual salary (including holiday pay) between €55.000,- - €80.000,-;
  • Profit sharing: maximum of 16%;
  • Days off: 40 per year;
  • Discount concerning insurance;
  • Discount on a gym membership.

  • CONTACT

    Tjeerd den Hartog

    +316 4668 3974

    [email protected]


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