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Regulatory Specialist - 6 months contract

This job is no longer available

Recruiter
Real Staffing
Posted
16 November 2012
Closes
14 December 2012
Ref
RE-12442706
Contact
Joseph Dykes
Location
Sector
Contract Type
Hours
Salary
£400 - £550 per day

Further information

RESPONSIBILITIES:

  • Explore strategies
  • Compliance in line with regulatory requirements
  • Document management
  • Write and maintain (update and review annually) risk assessments and support the maintenance of the device risk management files and overall risk management activity across the product lifecycle (e.g. to ISO14971
  • Write and maintain product submissions to relevant regulatory agencies (CE Notified Body, FDA,HealthCanadaetc.).
  • Assist the QSM with the calibration management activities
  • Manage post market surveillance activities

QUALITY OBJECTIVES:

  • To ensure that they are appropriately trained for the task they are to perform.
  • To ensure that the activities they conduct are in accordance with the quality system SOPs and company quality policy.
  • To ensure that they maintain and continuously improve their understanding of the international regulatory systems that apply.

KEY TASKS/DUTIES:

  • Creating necessary documentation to achieve the areas outlined above.
  • Investigating / assessing issues in order to achieve the areas outlined above.
  • Planning (including interfacing with colleagues) and executing such plans in order to achieve the areas outlined above

Please get in touch to understand this role further.

If this isn't suitable for you, do you know anyone that potentially would be?

We offer £200 referral vouchers for any successful referral.

KEYWORDS: DEVICES, MEDICAL DEVICES, 13485, 14971, ISO14971, REG, SPECIALIST, DEVICES, MED DEV, DEVICES, REGULATORY

To find out more about Real Staffing please visit www.realstaffing.com

Real Staffing

Real is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services.