Lead Regulatory Affairs Engineer
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Job Location:
Monthly Salary:
Posted on:
30+ days 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.
What youll do at Elekta
As a Lead Regulatory Affairs (RA) Engineer you will coordinate and manage the delivery of regulatory expertise across projects ensuring alignment with Elektas release and domain strategies. You will play a vital role in supporting regulatory submissions and maintaining compliance while also working ahead of project teams to ensure smooth execution and adherence to regulations. Your scope will include leading RA planning and backlog management supporting PI planning and acting as a deputy for the Director of RA when needed.
Key responsibilities include:
Act as functional interface to the Project Management Office for regulatory needs
Manage the RA task backlog and ensure resource planning in coordination with the Director of RA
Provide regulatory expertise across domain and release projects
Drive execution of RA management decisions
Proactively identify and lead continuous improvement opportunities
Support the development of departmental strategies and training
Represent RA in roadmap discussions and cross-functional planning
Participate in PI planning and raise regulatory actions for planning cycles
Ensure adherence to global regulatory and safety requirements
Support worldwide regulatory submissions including FDA Health Canada Japan and China
Deputize for RA Director and substitute for RA engineers when needed
The right stuff
Strong leadership and conflict resolution abilities
Ability to influence and build strong cross-functional relationships
Effective communication skills at all organizational levels
Collaborative mindset with the ability to mentor and drive problem-solving
Structured detail-oriented and able to work independently
Positive attitude toward change and continuous improvement
What you bring
At least 7 years of experience in Regulatory Affairs within the medical device industry
Proven project or program management experience preferably in Agile environments
Experience with radiotherapy or radiosurgery is a plus
Familiarity with international regulatory standards and submissions
BSc or MSc in Engineering or equivalent
Experience with quality assurance compliance and audits
Proficient in Microsoft Office and common IT tools
Excellent English language skills (written and verbal)
Experience working in a multicultural environment
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 they live - to have access to the best cancer addition to this Elekta offers a range of benefits.
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.
Your Elekta contact
For questions please contact the Global Talent Acquisition Partner responsible Gustaf Ericson at . We do not accept applications through 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.
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 6000 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 its personal and our global team of 4700 employees combine passion science and imagination to profoundly change cancer care. We dont just build technology we build hope.
Elekta is headquartered in Stockholm Sweden with presence in more than 120 countries and listed on Nasdaq Stockholm. For more information visit or follow @Elekta on Twitter and on LinkedIn.
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.
