Regulatory Communication Team Lead

Regulatory Communication Team Lead

Cook Medical

Limerick, Ireland

Overview

The primary function of this role is to lead a team of the regulatory communication specialists that serve as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS), Field Action and associated correspondence to applicable Regulatory bodies.

Agree objectives, generate training plans, coach team members, carry out performance appraisals and deal with performance related issues. Assess workload for the group and allocate tasks accordingly.

Responsibilities

• Provide leadership and mentoring to team members to ensure the effective completion of activities associated with their role;
• Fosters accountability within the team to meet established timelines;
• Mentors and trains new Regulatory communications team members;
• Assess complaints from Cook global shared service centres for adequate information to determine if event meets Regulatory Reporting requirements;
• Utilize appropriate complaint software systems for processing complaints to/from shared service centres and QE Investigation functions;
• Generate appropriate regulatory reports based on assessment;
• Liaise effectively with regulators on all issues with regard to regulatory reporting;
• Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner;
• Communicate with other Cook Companies globally as necessary for reporting;
• Generate responses to inquiries on AE reports from various global regulatory authorities;
• Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests;
• Input into the assessment of field action through the Health Risk Assessment process;
• Assist in coordination of Field Action administration activities between manufacturer and distribution centre;
• Close out of complaints as necessary;
• Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports. Maintains appropriate regulatory records to demonstrate compliance with applicable regulations;
• Maintain an excellent understanding of global medical device regulations;
• Responsibility for implementing applicable regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required;
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required;
• Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner;
• Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations;
• Identify and implement opportunities for improvement;
• Maintain a proactive approach to developing Cook’s Quality system to meet the changing needs of the business;
• Ensure that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner;
• Support of the Internal Audit and Regulatory Audit Programmes;
• Trending and analysis of key Quality metrics;
• Performs additional duties as assigned;
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf;
• Delegate for the Quality Engineering Manager.

Qualifications

• Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable;
• Previous supervisory experience would be beneficial;
• Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required;
• Knowledge of requirements in other jurisdictions where required;
• Knowledge of medical device quality standards/practises or similar regulated industry;
• Good communication and inter-personal skills;
• Proven problem-solving skills;
• Good computer skills including knowledge of Microsoft ® Office;
• Proven organisational skills;
• High self-motivation;
• Approved External Auditor;
• Willingness and availability to travel on company business.

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