Regulatory Affairs Manager - Medical

Job type:
on-site
Start:
n.a
Duration:
6 months
From:
Monarch Recruitment Ltd.
Place:
Essex
Date:
12/03/2019
Country:
flag_no United Kingdom
project ID:
1856073


Regulatory, OKM-BC, Medical

Regulatory Affairs Manager
Length of contract: 6 months
Location: Southend-on-Sea, Essex free. There is a free coach service 3 times in the morning and evening from major train stations around the area
To ensure the appropriate licensing, marketing and legal compliance of OKM-BC Medical and Industrial manufactured products.
The successful person will be responsible for getting the client through approval - interpreting requirements and putting together the info.
You will also be responsible for:
  • Ensuring continued compliance to all relevant regulatory and quality requirements
  • Timely identification and co-ordination of regulatory changes to ensure no negative impact on the business.
  • Successful completion of mandatory training
  • Compliance with Health & Safety and Environmental procedures.
For this role you will need:
  • Medical, surgical, endoscope experience ideal but no essential
  • Systems & Applications (level 2)
  • General & Operational Management expertise (level 1)
  • Departmental/Group Objective & Target Setting (level 1)
  • Training (level 1)
  • Process Validation (level 1)
  • New Product/Change Introduction (NPI & ECR/ECO) (Level 2)
  • University degree in a scientific/engineering subject.
  • Experience in a regulatory or quality role.
  • Ability to perform ISO audits and good understanding of EU MDD/MDR, FDA QSR and JPAL requirements and other key international regulations covering medical and industrial devices.