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Job Details


Regulatory Affairs Manager - Medical (Contract)

Location: Southend-on-Sea Country: UK
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 9001/13485 audits and good understanding of EU MDD/MDR, FDA QSR and JPAL requirements and other key international regulations covering medical and industrial devices.

Posted Date: 02 Dec 2019 Reference: JSMEDICAL 02 Employment Business: Monarch Recruitment Ltd. Contact: Kristen Furse