Regulatory Affairs Specialist
Elekta Instrument AB / Backofficejobb / Stockholm
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hela Sverige Visa alla jobb hos Elekta Instrument AB i Stockholm About the job- The Regulatory Affairs Specialist
As a The Regulatory Affairs Specialist within the market access team, you will act as a project leader and coordinator for Elekta's Regulatory submissions. You will have the responsibility to maintain and update the Regulatory Submission Roadmap, clearance status and work across all regions and product lines within the company. If needed the role would act as an internal consultant and support other functions within RA.
What You'll Do at Elekta
Proactively support the organisation in achieving and maintaining necessary regulatory clearances
Project manage regulatory submissions
Drive regulatory forums and monitor submission status
Support with database updates and regulatory system development.
Establish, manage, and implement Elekta's global Submission policies and procedures.
Communicate on daily basis with regional teams, business teams, local representatives, and regulatory authorities across the globe.
Support the organization with regulatory intelligence, global regulations, and regulatory requirements
What we believe you have
To succeed in this role, we anticipate that you have the following qualifications:
Degree in Life Sciences, MSc. in Engineering or equivalent
Excellent communication skills in both written and verbal English. Other languages such as Spanish, Russian, Portuguese and Chinese are a merit.
One to a few years of work experience from the medical device industry or other regulated industry. Knowledge of medical device regulations and previous experience of regulatory submissions is a merit, but we value the personal characteristics of the right person above your documented experience in the regulatory affairs field.
Solid decision-making skills and computer skills.
An open eye for the needs of your stakeholders and the ability to adjust to these needs.
Able to work to deadlines and solving issues in a pragmatic and proactive way.
You are able and willing to dig into the details yet keeping an eye on the overall goal.
What You'll Get
In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care. In addition to this, Elekta offers a range of benefits. Please note that depending on the location the benefits might vary.
Group Income Protection
Private Medical Insurance
Pension
Dependants' Pension
Retirement Policy
Life Assurance
Holiday Purchase
Cycle-to-work scheme
Flexible working hours
Hybrid work environment
Long Service Awards
Hiring Process
We are looking forward to hearing from you!
Apply by submitting your application and résumé in English, via the "Apply" button. Please note that we do not accept applications by e-mail.
We are an equal-opportunity employer
We are an equal-opportunity employer. We evaluate qualified applicants without regard to race, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, disability, veteran status, or any other protected characteristic.
About Elekta
As a leader in precision radiation therapy, Elekta is committed to ensuring every patient has access to the best cancer care possible. Elekta is a proud innovator and supplier of equipment and software used to improve, prolong, and save the lives of people with cancer and brain disorders.
More than 6,000 hospitals worldwide rely on Elekta technology. We openly collaborate with customers to advance sustainable, outcome-driven, and cost-efficient solutions to meet evolving patient needs, improve lives and bring hope to everyone dealing with cancer. To us, it's personal, and our global team of 4,700 employees combines passion, science, and imagination to profoundly change cancer care. We don't just build technology, we build hope.
Elekta is headquartered in Stockholm, Sweden, with a presence in more than 120 countries, and is listed on Nasdaq Stockholm. For more information, visit elekta.com or follow @Elekta on Twitter and on LinkedIn.
Så ansöker du Sista dag att ansöka är 2023-03-20
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Elekta Instrument AB (org.nr 556492-0949),
https://www.elekta.com/ Kungstensgatan 18 (
visa karta)
103 93 STOCKHOLM
Övrig information om företaget/organisationen Offentliga upphandlingar där Elekta Instrument AB varit leverantör Jobbnummer 7474116
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