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Senior Associate

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Expression of Interest

Location: Bangalore
Designation: Senior Associate (MDR Technical Documentation)
Department: Medical Device (EU/UKCA/US FDA)
Purpose of the Document: The document below assists employees in understanding the working pattern and job requirements for hybrid model (Home-Office) regulatory consulting services, as well as employers in understanding the employee’s desire and commitment.

1 I hereby submit the necessary information to the employer in order for them to examine my technical abilities, professional competence, and background check.
2 As a responsible professional, if I am selected, I pledge to respect the confidentiality of all customer-supplied information and technical specifications with the atmost care.
3.1 Annual Professional benefit: 1200000 - 1400000 INR
3.2 Relocation cost and 2BHK Accommodation offered
3.3 Future increments are based on your technical capability, problem resolution, Utilization of man-days, handling of customer queries and concerns and overall profit generation from the allocated projects.
3.4 TDS will be deducted as per India Govt Rules.
3.5 Additional project completion rewards may be eligible.
4 Working from Monday to Friday. Weekly off Saturday and Sunday.
4.1 Work Timing 0900 - 1800. 8 Hours per day. 40 Hours per Week
4.2 A weekly office visit is required, with the option of working from home on the other days.
5 During working hours employees must be accessible at any point of time on Skype, Mobile, WhatsApp & Email (Outlook).
5.1 All incoming calls from clients and team members must be answered on all working days days including Saturdays.
5.2 Candidates are required to maintain the same contact number throughout the tenure.
6 Candidates will be provided domain linked Email ID for communication and the same must be used for Skype and Dropbox and all other related applications. The password should be protected.
6.1 All critical technical matters should be communicated through emails only. Avoid verbal communication.
6.2 All internal communication via Skype and WhatsApp and Outlook application.
7 Job Responsibilities.
7.1 Develop optimization strategies that increase the per-head output. Timely completion of projects with limited resources
7.2 Lead a team of 25 members by appropriate project planning and allocation of activities based on project timeline
7.3 Review and comment on project related documents developed by junior members on daily basis throughout the development stage and NB review stage
7.4 Project updation and daily meetings with team leads and project head
7.5 Training new employees and assessing their performance
7.6 Meeting global customers onsite and offsite based on schedule. Attend weekly meeting
7.7 Assure Notified Body acceptance of technical documentation.
8 Job Requirements.
8.1 Through knowledge in EU 2017/745 with hands-on experience in clearing 10-15 technical files.
8.2 Through knowledge in risk management, biological evaluation, harmonized standards.
8.3 Basic knowledge in PMS, PMCF, MEDDEV 2.7.1 Revs 4 and 2017/745 Article 61.
8.4 Real-world experience interacting with notified Bodies.
8.5 Experienced in cloud documentation.
9 Management Requirements.
9.1 Leaves must be informed in advance for the smooth planning and scheduling the internal activities.
9.2 Candidates must intimate at least 90 days prior intimation about career change / Resignation.
9.3 Management has the right to terminate (a) if the candidates does not fulfill the responsibilities (b) find difficult managing the team c) poor team work and(d) poor time management
10 Applicant Declaration.
10.1 Myself willing to work in the organization and would like to be a part of I3CGLOBAL team for a minimum period of 2 years from the date of joining at my present capacity and family circumstances.