Regulatory communication Team Lead
Job ID: JOB-13341
Regulatory Communication Team Lead
The primary function of this role is to lead a team of the regulatory communication specialists that serve as a communication liaison between the manufacturer and the 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.
- 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 global shared service centers for adequate information to determine if event meets Regulatory Reporting requirements.
- Utilize appropriate complaint software systems for processing complaints to/from shared service centers 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 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 center.
- 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 Manufacturer and the International local office and/or distribution partner.
- Maintains and organizes appropriate regulatory records to demonstrate compliance with applicable regulations.
- Identify and implement opportunities for improvement.
- Maintain a proactive approach to developing the Quality system to meet the changing needs of the business.
- Ensure that in-house or external Quality issues are effectively prioritized and acted upon in a timely manner.
- Support of the Internal Audit and Regulatory Audit Programmers.
- Trending and analysis of key Quality metrics.
- Performs additional duties as assigned.
- Ensure that the Code of Conduct is considered in all business matters carried out on their behalf.
- Delegate for the Quality Engineering Manager
- 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 organizational skills.
- High self-motivation.
- Approved External Auditor.
- Willingness and availability to travel on company business.
For further information on this role in Limerick please contact Aisling Kidney on 0872197421 or email@example.com
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