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Details

Director of Regulatory Affairs


Reference:KG-ANMV-566147 Location: Republic of Ireland
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Would you like to join a leading and successful medical device company in Ireland, to further develop your career? This is an excellent opportunity to work with leading technologies in the medical device industry, in a Strategic Director level role.

TheDirector ofRegulatory Affairsis responsible for leading regulatory team, regulatory strategy, 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.

TheDirector of RegulatoryAffairsis also responsible for working with sister manufacturers,to assist with communications with relevant authorities and to provide clarification and advice on regulatory requirements.Taking global functional direction theDirector of RegulatoryAffairsis a member of the seniormanagement team and the global Regulatory Affairs leadershipteam.

Responsibilities:

  • Direct, mentor and lead 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 where products are for sale.
  • Ensure the outputs from the individual functional units (engineering, marketing, clinical, clinical communications etc.) meet the applicable marketing authorisation requirements as necessary.
  • Ensure that products are appropriately registered and maintained in all countries where they are for sale - manage and maintain country restrictions as necessary.
  • Person Responsible for Regulatory Compliance (PRRC) as per EU Regulations.
  • Ensure that the technical documentation and the declarations of conformity are drawn up and kept up-to-date.
  • Ensure that the post-market surveillance obligations are compiled with as per current EU regulations.
  • Ensure that the reporting obligations of the EU MDR are fulfilled.
  • 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


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.
  • Only candidates with Medical Device or Pharmacuetical industry expereince will be conisdered.
  • 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.


Employee benefits include:

  • Life Assurance and Income Protection cover
  • Educational Assistance
  • Company sponsored Defined Contribution pension scheme
  • Medical Health Insurance cover for you and your immediate family
  • Extensive health & wellness program
  • Fully equipped gym on site
  • 39-hour week with flexible start & finish times
  • Paid time off to participate in volunteer activities
  • Free parking
  • Subsidised restaurant
  • Sports & Social club


If you meet the Qualifications/Requirements, and feel this is a good role for you, please apply today!