Medical Device, Quality/Risk Management, Regulatory Compliance
4 Year Degree
The Director of Regulatory Affairs is responsible for Cook Ireland's 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. The Director of Regulatory Affairs is a member of the CIRL senior management team and the global Regulatory Affairs leadership.
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 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.
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.
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.
Provide coaching and support to direct reports in their day to day roles 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 at Cook Ireland to drive efficient processes.
Follow local policies and procedures including but not limited to health and safety, human resources, travel and expense reporting
Designees for this position are the Regulatory Affairs Managers.
Ensure that Cook’s Code of Conduct is considered within all business matters carried out on Cook’s behalf.
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.
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.
Excellent communication skills and the ability to interact effectively with all levels of the organisation.
Willingness and availability to travel on company business.
Internal Number: 5614
About Cook Medical
Cook Medical has been in Limerick since 1993, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support, and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 800 people and manufactures 10 percent of Cook’s products for global markets.