İlan Detay
  • PDA
  • PFO
  • PLD
  • UNI

Occlutech Tıbbi Ürünler - Regulatory Manager And PRRC

Job Definition

The RA Manager will ensure that product regulatory requirements are met in their support function to R&D, as well as preparing and assembling regulatory submission and support files for the regiatration of the medical devices in accordance with GMP, ISO 13485, MDD 93/42/EEC, MDR 2017/745, ISO 14971, and related country regulations for medical devices.

  • Assist in the assessment of R&D activities
  • Review changes to existing Istanbul products and global RA SOPs to define the requirements for regulatory product compliance, as necessary.
  • Maintain current knowledge of international regulation, guidance and standards that relate to registration requirements and to applicable to company products.
  • Actively participate in evaluation of regulatory compliance of document / product / process / test methods changes.
  • Participate in research of regulatory issues and dissemination regulatory information to Production, QMS and R&D departments and senior management as required.
  • Review, approve, develop or assist in the development of regulatory and product technical documentation:
  • Person Responsible for Regulatory Compliance (PRRC) as per REGULATION (EU) 2017/745, article 15, 3 (b).

Qualifications

  • More than 2 years experiences
  • Min. BA degree graduate
  • Military status should be completed
  • Excellent interpersonal and communication skills
  • Ability to manage multiple projects effectively & excellent organizational skills
  • Fluent in English
  • Moderate travel may be required