Due to a promotion an opportunity has now become available for a Director of Regulatory Affairs CMEU to assume responsibility for CMEU’s regulatory strategy and systems including the EU Authorised Representative (AR) Office. The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical’s non-EU manufacturers. The Director of RA acts as the Person Responsible for Regulatory Compliance (PRRC) as per Article 15 of the EU MDR. The Director of RA is a member of the Location Leadership group.
As this role was created as a result of EU MDR, the initial responsibility is to manage and direct the global EU MDR Project to ensure that all Cook Manufacturers are compliant to the new regulations, to enable the EU AR to fulfil its duties.
Reporting to: Managing Director CMEU/Executive Vice President EMEA with a dotted line to Global Director, Regulatory Affairs
Global MDR Project
Direct and manage the Global MDR Project as follows:
Effectively and efficiently schedule all the project activities and timelines to ensure the project objectives are met and delivered within the agreed timeframe.
Work with local entities in identifying and resolving resource gaps where necessary. Communicate the plan to local entity leadership teams to ensure buy-in at entity level.
Monitor, track and communicate project progress in a structured and timely manner to Steering committee, Cook Medical Executive team (CME) and key stakeholders.
Lead and mentor project teams to ensure that each member understand their role and responsibilities and meets his / her objectives within the scope of the project, escalating issues and take action to address concerns or slippages as appropriate.
Anticipate regulatory and other obstacles/ risks and emerging issues throughout the project lifecycle and develop solutions with relevant functions and related teams, taking action as necessary to avoid delays.
Be cognisant of departmental expenditure and budget.
Meet and engage as directed with regulatory authorities (Competent Authorities, Notified Bodies and global regulatory agencies as required) to understand their needs and expectations.
Liaise with Corporate Communications to provide updates across the company.
Director of RA CMEU
Direct, mentor and manage the Regulatory Affairs department ensuring resources and expertise are assigned to meet company goals, objectives and to ensure regulatory compliance.
Ensure processes and procedures are put in place as part of the CMEU QMS to carry out the role of EU AR as per Article 11 of EU MDR and per the MDD
Fulfil the role of the Person Responsible for Regulatory Compliance (PRRC) as per Article 15 of the EU MDR. Maintain close contact and links with relevant Cook manufacturing sites and ensure contracts / Mandates are in place between the EU AR and Cook manufacturers that the EU AR represents.
Liaise with and respond to request for information and/or documentation from Competent Authorities. Inform relevant CA’s of any reportable incidents and field safety corrective actions.
Monitor post-market surveillance as necessary.
Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EUMDR 2017/745 and additional EMEA regulations as required.
Identify and monitor legislative and regulatory activities, update processes and procedures as appropriate and report their potential impact on the company to local and global leadership as necessary.
Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution partners.
Manage regulatory costs and ensure a full understanding of departmental expenditure and budget.
Contribute and work as part of the location leadership team to help create a synergistic and cohesive environment.
Ensure compliance to the Quality Management System and Business Processes.
A third-level science or engineering degree together with a relevant regulatory science qualification and/or relevant training.
10 years’ experience in a busy regulatory environment with responsibility for multiple medical device classes including class three devices.
In-depth knowledge of the EU MDR and its requirements for manufacturers and economic operators.
Experience of dealing directly with regulatory authorities such as CA’s, FDA, etc. including submissions, responses to queries, incident reporting and field actions.
Proactive and highly motivated; excellent interpersonal and communication skills.
Strong organisation skills – ability to prioritise and deal with multiple issues.
Flexibility to work outside of normal business hours from time-to-time.
Willingness and availability to travel on company business as required – this will include visits to Cook manufacturers as well as meetings with regulatory authorities and participation in Cook RA meetings and inter-functional meetings.
About Cook Medical
Since 1963, Cook Medical has been finding solutions to improve the world’s healthcare problems for the patients and doctors we serve. As one of the world’s largest private companies, we have always operated with our patients, customers, employees and communities at our core. We do this, not only because it is good business, but also because we believe that being a good corporate citizen is the right thing to do.
Cook Medical has been in Limerick since 1993. Since opening, we have become a European headquarters for many of Cook’s business functions.
With a global workforce of 12,000, we employ over 850 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialisation.
Regulatory in Limerick
In Limerick we have more than 35 talented & experienced Regulatory professional working in two distinct Regulatory teams, with Regulatory Global leadership based in Limerick also.
Our CMEU regulatory team are responsible for our EU-Rep office. This provides a centralised European office to manage Cook’s responsibilities under EU MDR and ensure a focused and consistent approach to compliance for our medical devices in EMEA. The team are Cook Medicals point of contact for EU regulators. The Cook global implementation for EU MDR is led from this office to ensure that our 8 manufacturing sites globally have a consistent approach to achieving EU MDR compliance in a timely manner.
Our CIRL Regulatory team are responsible for global regulation in over 60 countries, managing pre- & post- market regulation for all product classifications and novel devices across EMEA, AMER and APAC. The team works cross functionally with clinical, quality and engineering during the design process and throughout the device lifecycle. The Regulatory Affairs CIRL team are RA are also involved in a broad range of activities including marketing authorization and submissions, vigilance and adverse event reporting and clinical evaluation.
Both of our Regulatory Affairs teams are central to holding Cook to the highest standards because everything we do has an impact on someone’s life.
Our employee benefits include:
Life Assurance and Income Protection cover
Company sponsored Defined Contribution pension scheme
Medical Health Insurance cover for you and your immediate family
Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks
Fully equipped gym on site
39-hour week with flexible start & finish times
Paid time off to participate in volunteer activities