Regulatory Affairs Manager

Job type:
permanent
Start:
11/2015
Duration:
n.a
From:
Real Staffing
Place:
Waterford
Date:
10/17/2015
Country:
flag_no Ireland

Project description:
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This project is archived and not active any more.
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I have an immediate opening for a Regulatory Affairs Manager with a leading medical device company based in Waterford.

This is a senior role reporting to the Quality Director. The candidate will provide support for the change management process including governance and QPI metric reporting. Provide international support for regional regulatory requests such as adding new products, registration renewal, registration support

Person Specification
* Bachelor's Degree in Engineering or scientific discipline (Chemistry, Biology, Microbiology or related technical field)
* Minimum 5 years' experience in medical devices/pharma, ideally in Regulatory Affairs, R&D Quality or Operational Quality
* Previous RA experience is essential preferably in the medical device area
* Self starter, motivated individual required

Responsibilities
* Provide direct support for change management including regulatory assessments, change governance, monthly QPI metric reporting
* Facilitate global regulatory assessments using a structured process and through engagement with our international regulatory professionals and international change committees
* Primary contact/driver for regional changes. Support site change implementation managers to drives changes that affect markets
* Serve as local focal point for change requests of the various regions, along with requests for information supporting global product registrations.
* Various activities in change management including:
o Processing changes from the sites and external sources to the COC for review
o Provide management with appropriate measures of system performance
o Identify and resolve situations where regionally approved changes lose momentum or become dormant

* Work within a peer team structure to develop the underlying processes for this group including performance measures. Based upon system feedback drive continual improvement in associated QPI's.
* Provide direct support for international requests regarding registration maintenance, renewal, addition of new products or SKU's. These activities include:
o Providing single point of contact for the regional informational requests for registration support and country specific requirements
o Create informational repository for regional regulatory requests including the addition of new products

* Help solidify and strengthen the global change management network and process through proactive engagement with international peers and key stakeholders.
* Provide training as required to both international and domestic groups in support of the whole process

If you are interested in hearing more about this excellent opportunity please apply directly to this advert or contact Derek Sheridan at