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Regulatory Affairs Director

Reference ID : NHCL03
Category :
  • Medical Devices
Date Posted : Mar 20, 2019
Job Location
  • Munster
- Limerick
Experience : 10+ Years
Salary : Neg
Employment Type
Nicola O'Sullivan
Contact Number : 0870622429
Reg Affairs Director required for Med Device multinational

Principal Responsibilities

Regulatory Affairs Director


Headcount Engineering are currently recruiting for a Regulatory Affairs Director on behalf of our client, a Munster based global leader within the medical device industry.  The successful candidate will be responsible for regulatory strategy and systems, and for ensuring that the company's products meet regulatory requirements in markets where they are for sale; including appropriate reporting of adverse incidents where applicable. The Director of Regulatory Affairs is also responsible for working with sister manufacturers, to assist with communications with relevant authorities and to provide clarification and advice on regulatory requirements.


Key Responsibilities:

  • Direct, mentor and manage the Regulatory Affairs department ensuring resources and expertise are assigned to meet company goals and objectives.
  • Ensure the regulatory systems and procedures meet the necessary regulatory requirements pertaining to company registration and product marketing authorisation.
  • Ensure the outputs from the individual functional units (engineering, marketing, clinical, clinical communications etc.) meet the applicable marketing authorisation requirements as necessary.
  • Ensure products are appropriately registered and maintained in all countries where they are for sale - manage and maintain country restrictions as necessary.
  • Ensure that as directed by sister companies their products are appropriately registered and maintained for sale within the EMEA - manage and maintain their country restrictions as necessary
  • Ensure that complaints are assessed for regulatory reporting including the associated correspondence to applicable regulatory authorities.
  • Provides regulatory support to functional units such as CSD, DCM, Engineering, Quality Assurance and Operations.
  • Liaise with regulatory authorities as necessary and appropriate for both pre-market authorisation and post market surveillance activities.
  • Official Correspondent/Contact Person for regulatory authorities as required.
  • Meet and engage with regulatory authorities to understand their needs and expectations.
  • Develop and advise on regulatory strategies for new, existing and changing products in collaboration with Engineering, Quality Assurance, Divisions, clinical and other stakeholders as appropriate.
  • Undertake people management responsibilities to the direct reports to this role, including but not restricted to, generating training and development plans, carrying out performance appraisals and dealing with performance related issues.

Qualifications & Requirements


  • Bachelor's degree in life sciences or chemistry. An advanced life science degree (e.g. MS, PhD) is preferred.
  • Minimum of 10 years’ experience in medical device regulatory affairs.
  • Solid working knowledge of European regulatory environment.
  • Strong strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills; highly organised.
  • Proven ability to interact in a group environment, have strong interpersonal skills and the ability to establish and maintain effective relationships with all stakeholders.
  • Thorough understanding of GLP, GCP, GMP, FDA and ICH guidelines.
  • Excellent written and oral communication skills; a detail-oriented work style and the ability to handle multiple tasks.
  • Must be able to work under pressure and meet deadlines.
  • Ability to present facts and recommendations effectively in oral and written form.
  • Willingness and availability to travel on company business.

For more information and a full job spec contact Nicola on 087 0622429 or email your CV in the strictest confidence to jobs@headcount.ie 


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