Director, Regulatory Affairs - CIRL

Director, Regulatory Affairs - CIRL

Cook Medical

Limerick, Ireland

Overview

The Director of Regulatory Affairs is responsible for leading the Cook Ireland 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. 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. Taking global functional direction the Director of Regulatory Affairs is a member of the CIRL senior management team and the global Regulatory Affairs leadership team.

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 CIRL’s 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 CIRL 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 Regulation (EU) 2017/745.
    • 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 (Article 10 (10)) of the MDR:2017.
    • Ensure that in case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
    • Ensure that the reporting obligations referred to in Articles 87 to 91 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.
  • Ensure that complaints are assessed for regulatory reporting including the associated correspondence to applicable regulatory authorities.
  • Provides regulatory support to Cook 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 (Competent Authorities, Notified Bodies and global regulatory agencies as required) 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.
  • Work with regulatory groups locally and globally to develop and implement strategies for the most efficient and timely submission and approval of regulatory filings.
  • Identify and monitor legislative and regulatory activities and report their potential impact on the company to local and global leadership as necessary.
  • Ensure compliance to global policies, procedures and direction.
  • Manage regulatory costs and ensure a full understanding of departmental expenditure and budget.
  • Contribute and work as part of the CIRL senior management team to help create a synergistic and cohesive environment.
  • Provide mentorship, coaching and support to direct reports and act as a point of escalation where necessary for specific issues that may arise.
  • Ensure open communication channels are maintained across all teams within the Regulatory function, and that all relevant information is cascaded appropriately and in a timely fashion.
  • Seek out continuous improvement best practice with an emphasis on what can be learned and implemented to drive a best in class operation and efficient processes.

Qualifications

  • 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.
  • Proficient use of Microsoft Office applications is required. Additional experience with databases and report writing is a plus.
  • Must be a strategic team builder with good business acumen, combined with hands-on approach.
  • Willingness and availability to travel on company business.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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