Assistant Manager- Regulatory Affairs

Tilganga Institute of Ophthalmology
Location: Nepal
Salary: Negotiable
Posted Date: 2017-08-29 Deadline: 2017-09-12
  • Nos. of Opening : 1
  • Location : Nepal
  • Working Position : Entry Level
  • Qualification Degree : Masters in Pharmacy or Microbiology-environment.
  • Salary : Negotiable
  • Category : Management / Operations
  • Nature : Full Time
Job Description

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.

Qualification:

  • 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.

Responsibilities:

  • 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.

Apply Instructions

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.

This Job is expired. The Company is no longer accepting applications for this position.

Organization Summary

Nepal Eye Program was officially launched in July 1992 to support the prevention & control of blindness in Nepal and the region. Tilganga Institute of Ophthalmology (TIO) is the implementing body of the Nepal Eye Program, a not-for-profit, community-based, non-government organization. With an aim to act as a model for treatment, research and training, independent yet working in co-operation with all other eye care centres and organizations in Nepal, the current TIO facility was opened in 1994.

In the early years, working with The Fred Hollows Foundation (FHF), Australia, TIO played a key role to help refine and adapt a practical, safe, and affordable technique of intraocular lens implant for cataract surgery in developing countries. Another key achievement in the early days was the establishment of the country's first eye bank, in conjunction with Tissue Banks International in Baltimore, USA, and Lions International.

Industry Type Hospital / Clinic
Location Gaushala, Bagmati Bridge P. O. Box # 561 Kathmandu Nepal Phone: +977-1- 4493775, 4493684
Organization Size 1-10
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