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My client is looking for a Regulatory Affairs Manager for consultancy role to the Medical Devices Sector for an immediate start.

B.Sc. Minimum or Pharmacy primary degree.
Minimum experience within Regulatory Affairs or Compliance in a Medical Device Environment
Be an authority on EU Medical Device Directives and be able to provide support as necessary
Strong commercial awareness and an innate ability to assess the commercial implications of decisions and
advice.
Excellent written and oral communication skills.
Ability to project manage across a diverse and complex portfolio of products and priorities.
Ability to get on with people, to influence people both internally and externally and to achieve objectives.
Attention to detail and solid interpersonal, communication and organisational skills required.
Ability to work on own initiative with minimal supervision, self starter and as part of a team.


PURPOSE / KEY RESPONSIBILITIES:
Ownership/ regulatory responsibility for a portfolio of products for nominated client and be responsible for
close liaison with the Management/ other key personnel of the relevant business unit in the definition of
product strategies in line with timeframes for approval.
Builds and maintains strong relationships with EU Health Authorities as appropriate to ensure ease of access
and influence.
Ensures customer queries are handled in appropriate manner and comprehensive manner, and records are
kept of all communication both external and internal.
Be an authority on the regulatory framework in Ireland and Europe in particular in the Medical Device area
Supports EU regulatory initiatives and issues as appropriate
Works collaboratively with other department colleagues to share best practice and information
Management / review of Non-conformances
Preparation of Annual Product Reviews and generate documents as necessary for management review
To ensure that all activities relating to associated Internal Audits are carried out and to co-ordinate the preparation activities for External audits



Contact : Eoin Coffey
Adecco Recruitment
061 413617