Date of Publication:August 29, 2017 Nepal Eye Program, Tilganga Institute of Ophthalmology (710), a centre of excellence in comprehensive eye care service delivery including training; research: intraocular lens manufacturing facility: community program and eye bank is currently looking for qualified Nepali candidates to apply for the following positions on the contract basis:
Assistant Manager- Regulatory Affairs—(No. of Requirement :1)-
Level 8 Assistant Manager-Regulatory Affairs will be responsible for the responsibilities as described and s/he shall assist QA department in regular course of work.
- Masters in Pharmacy or Microbiology-environment.
- 2 years of proven experience in regulatory affairs or document handling in a Pharmaceutical or other ISO. CE certified Industries.
- Quick learner and ability to understand process and guidelines of ISO, CE requirements
- Sound physical health.
- Age shall not be more than 40 years for ladies and not be more than 35 years for gentleman.
- Computer and data processing skill.
- Ensures the overall regulatory strategy aligns with the target product profile, ISO 9001, ISO 13485 and MDD 93/42 ECC.
- Represent organization and liaison for the ISO, CE audit.
- Coordinates with QA and other department for the development of regulatory strategies for new medical devices as part of product registration.
- Developing legislation: regulatory policy and technical regulatory guidance. SOPs relating to products and understand the impact on current and future submissions.
How To Apply
Candidates who are meeting above said criteria are requested to submit the application letter with updated curriculum vitae and transcript of bachelor and master to hr_vacancy@ tilganga.org no later than 5.00 pm: September 12; 2017.
Only shortlisted candidates will be contacted for further selection process. The TIO reserves the right to reject any or all application(s) without stating any reason whatsoever.
Remuneration and benefits will be provided as per Nepal Eye Program contract rules.
Tilganga Striving for excellence