SENIOR ASSOCIATE (I3CLMG060)

I3cglobal; Bengaluru; On-site; INR 1,200,000 - 1,400,000; Full time

Benefits offered by this job

Annual professional benefit: 1,200,000 – 1,400,000 INR

Relocation cost and 2BHK accommodation offered

Future increments based on performance

Eligibility for additional project completion rewards

Job summary

I3cglobal is looking for a Senior Associate (MDR Technical Documentation) in Bengaluru. The role involves leading a team of 25 in regulatory consulting and ensuring project completion within timelines.

The candidate will work in a hybrid model, with responsibilities including developing strategies, reviewing documents, and training new employees. Solid knowledge of EU regulations and hands-on experience with technical documentation is essential.

Qualifications

• Hands-on experience in clearing 10-15 technical files.
• Knowledge in PMS and PMCF.
• Familiarity with harmonized standards.

Responsibilities

• Develop optimization strategies to increase output and complete projects on time.
• Lead a team of 25 members effectively.
• Review project-related documents and provide feedback.
• Conduct training for new employees.
• Attend weekly meetings with global customers.

Skills

Knowledge in EU 2017/745 with hands-on experience in clearing technical files

Knowledge in risk management

Biological evaluation expertise

Real-world experience interacting with notified bodies

Experience in cloud documentation

Job description

Location: Bangalore

Designation: Senior Associate (MDR Technical Documentation)

Department: Medical Device (EU/UKCA/US FDA)

Purpose: The document below assists employees in understanding the working pattern and job requirements for a hybrid model (Home-Office) regulatory consulting services, as well as employers in understanding the employee’s desire and commitment.

Benefits

• Annual professional benefit: 1,200,000 – 1,400,000 INR
• Relocation cost and 2BHK accommodation offered
• Future increments based on technical capability, problem resolution, utilization of man‑days, handling customer queries and overall profit generation from allocated projects
• TDS will be deducted as per India Government Rules
• Additional project completion rewards may be eligible

Work Schedule

• Working from Monday to Friday; weekly off Saturday and Sunday
• Work timing 09:00 – 18:00. 8 hours per day. 40 hours per week
• A weekly office visit is required, with the option of working from home on the other days
• During working hours employees must be accessible at any time on Skype, Mobile, WhatsApp & Email (Outlook)
• All incoming calls from clients and team members must be answered on all working days including Saturdays
• Candidates must maintain the same contact number throughout the tenure
• Domain linked Email ID will be provided and must be used for communication (Skype, Dropbox, Outlook). Password should be protected
• All critical technical matters should be communicated through email only; avoid verbal communication
• Internal communication via Skype, WhatsApp and Outlook application

Responsibilities

• Develop optimization strategies that increase per‑head output and ensure timely completion of projects with limited resources
• Lead a team of 25 members by appropriate project planning and allocation of activities based on project timeline
• Review and comment on project‑related documents developed by junior members on a daily basis throughout the development stage and NB review stage
• Project updating and daily meetings with team leads and project head
• Training new employees and assessing their performance
• Meeting global customers onsite and offsite based on schedule; attend weekly meeting
• Assure notified body acceptance of technical documentation

Qualifications

• Knowledge in EU 2017/745 with hands‑on experience in clearing 10‑15 technical files
• Knowledge in risk management, biological evaluation, harmonized standards
• Basic knowledge in PMS, PMCF, MEDDEV 2.7.1 Revs 4 and 2017/745 Article 61
• Real‑world experience interacting with notified bodies
• Experience in cloud documentation