Regulatory Affairs Engineer – Post Market Surveillance
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Job Location:
Monthly Salary:
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Are you a current Elekta employee
Please click here to apply through our internal career site Find Jobs - Elekta.
Want to join a team with a mission to improve and save lives
We continually look for motivated and skilled individuals who are interested in supporting our customers healthcare professionals who use our products to help patients and their communities.
We currently have the following opportunity available - please contact us for more details!
We dont just build technology. We build hope for everyone dealing with Cancer.
Are you ready to play a vital role in ensuring patient safety and regulatory compliance in the medical technology space At Elekta were seeking a Regulatory Affairs Engineer to join our Post Market Surveillance team where youll help manage and resolve product complaints in line with global regulatory requirements.
Reporting to the Regulatory Operations Manager youll be responsible for overseeing complaint handling ensuring timely reporting to authorities and maintaining a robust escalation system. Youll also collaborate across functions to support broader post-market activities as priorities evolve.
If youre detail-oriented proactive and passionate about improving lives through precision healthcare wed love to hear from you.
What youll do at Elekta:
Your role will include but not limited to
Developing implementing and maintaining appropriate and consistent systems and procedures to meet the business objectives
As a member of the complaint unit ensure that all product safety cases are quickly identified assessed for patient risk and escalated appropriately to ensure proper action and /or agency notification is taken
Ensure the reporting of adverse events to the appropriate authorities are carried out within specified timeframes
Liaise with external regulatory bodies and internal regulatory functions within Elekta on AE reportable complaints
Provide awareness training as required to ensure that everyone in the Business is aware of the importance of Complaints and the need to deal with them in a timely manner
Monitor that complaints are closed in accordance with the defined targets and make raising non-conformances where necessary
Any other Post Market Surveillance activities as required to support the departmental goals
The right stuff:
Excellent communication skills enabling independent and interactive working across the global Elekta organisation
Ability to work within a multi-cultural environment and across time zones
Willingness and ability to travel domestically and internationally
What you bring:
*We encourage you to apply even if you dont meet every requirementyour unique skills and experiences might be exactly what were looking for!
Advanced qualification or experience in the medical device industry preferably with global exposure
Knowledge of Medical Device Regulatory Affairs specifically Post Market Surveillance and Vigilance
Experience with complaint handling requirements in the medical device industry
Proven experience in regulatory affairs within the medical device industry with a strong focus on post-market surveillance vigilance and product recalls.
In-depth knowledge of EU and US medical device regulations including hands-on experience with notified body audits.
What youll 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 addition to this
30 paid vacation days/year additional 4 Elekta days off /year
Attractive defined contribution pension scheme
Private Medical Insurance
Lunch Benefit
Contribution to wellness activities
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 age race colour religion sex sexual orientation gender identity genetic information national origin disability veteran status or any other protected characteristic.
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Helping clinicians treat cancer & brain disorders through precision radiation medicine. Our radiotherapy treatments target the tumour & protect the patient.
