Occlutech Tıbbi Ürünler - Regulatory Manager And PRRC
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).
- 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