Website Elexes Medical Consulting
Elexes Medical Consulting is a Medical Devices QA & RA firm catering to clients across the world. As a member of the ELEXES team, you will be responsible to support company regulatory objectives in the maintenance of documentation and ensuring the utmost quality and accuracy at all the times. You need to use organizational skills and meticulous attention to detail to support regulatory projects. You will be a key contributor to the continued success of all submissions to regulatory agencies.
Currently, Elexes is looking for freshers who are passionate about taking up a career in the field of regulatory affairs. The candidate must work on projects in coordination with the Management based solely on their performance as assigned and coordinated by the Management.
The candidate will have to-
1. Work on latest and new technologies that are achieving a breakthrough in the medical field/medical science.
2. Be a part of a technical team to provide regulatory guidance to the clients to support optimal timelines for new/modified product launches.
3. Manage your Client’s projects, timelines, and deliverables.
4. Draft and finalize all design documentation based on Supervisor’s review.
5. Support the optimization of design control elements to comply with medical device regulations.
6. Support the efforts associated with worldwide regulatory submission (e.g., 510k Submissions, FDA correspondences) as assigned.
7. Support in the creation of regulatory strategies for projects.
8. Draft verification and validation test protocols.
9. Draft and finalize FMEAs and risk assessments.
10. Create and remediate Design History File (DHF) of Medical Device.
11. Leverage deep scientific and technical understanding of regulated products under the scope of responsibility to derive project execution.
12. Assess device failures and draft risk controls.
13. Work with several standards like IEC 60601-1, IEC 60601-1-2, IEC 61010-1 & ISO 13485
The Regulatory Affairs Associate will-
1. Draft and finalize all design documentation
2. Support the efforts associated with worldwide regulatory submission (e.g., 510(k) Submissions, FDA correspondences) as assigned
3. Draft verification and validation test protocols
4. Draft and finalize FMEAs and risk assessments
5. Create and correct Design History File (DHF) of Medical Device
6. Draft quality management system SOP
The candidate must possess a Bachelors or Masters degree in Biomedical Engineering, Biotechnology, Electronics and Instrumentation Engineering or Mechanical Engineering.
Other soft skills that we will look for are as follows-
1. Good knowledge of concepts and understanding of various technologies used for the creation of medical devices
2. Ability to learn and adapt quickly
3. Interest in medical device innovation
4. Excellent English writing and verbal skills
5. Ability to communicate complex information in a simple manner
Our interview process is outlined as below:
1. Round 1 -Online Questionnaire Interview of duration 1 hour
2. Round 2 -Onsite Interview- Technical Written
Salary/CTC – We offer a package of 3 to 4 LPA CTC. Depending on the candidate, there will be a 20% to 40% annual growth based on performance.
Elexes Medical Consulting is and will experience a steady growth trajectory in the upcoming year, 2019. Thus, the company will be open to offering the role of Project Lead with an increment of 10-15% every six months to one year based on the performance of the candidate. As such, we are looking for candidates who are motivated, self-driven, capable to possess excellent attention to detail abilities and are susceptible to adapt to our fast-paced environment.
To apply for this job email your details to firstname.lastname@example.org