Regulatory Specialist - 6 months contract

Hampshire
£400 - £550 per day
16 Nov 2012
14 Dec 2012
RE-12442706
Joseph Dykes
Engineering
Contract
Full Time

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

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