On behalf of our client, a leading medical and healthcare company, we are currently recruiting for a Compliance Officer for a maternity contract cover. This will be approx 9-12 months duration. The role is hybrid within the Dublin office - 2 days in the office and 3 days remote.
The Compliance Officer will have responsibility to lead and drive the management and maintenance of The Quality Management System and regulatory systems in place. You will provide compliance and quality assistance to the highest international standard, across a broad range of areas including ISO and Health Care Compliance. Reporting to the Human Resources Manager, you will work closely with members of the Business Teams. You have strong people management skills and are tenacious in overcoming objections or resistance to achieve your goals and drive the company-wide compliance program.
Responsibilities: Reporting to the HR Manager, your role and responsibilities include:
· Healthcare Compliance - Leads and drives the Health Care Compliance (HCC) program to ensure business practices are compliant with internal guidelines and regulatory requirements
· Review and approval of events including Educational Grants, Professional Education, Promotional Events, company Events
· Deviation - maintain deviation log
· ISO – General upkeep of the quality system in terms of ISO 9001 and 13485 standards and the online documentation system
· Completion of internal audits and supporting the hosting of customer audits (point of audit set up and Quality Department representative during audits)
· Review/lead process investigations and ensure any such investigations are documented appropriately with relevant corrective actions, if necessary
· Maintain the Risk Register and conduct Risk Assessments where appropriate
· Incident and Breach Management
· Liaise with HPRA as required
· Perform additional assignments as directed by the manage
The Person:
You are someone with an ability to get things done who is looking to join a leading Medical Company and a Great Place to Work. You demonstrate accountability and strong commercial awareness allowing you to adapt quickly in line with business changes. You have excellent communication, organisational and problem-solving skills. You are self-motivated and constantly seeking smarter ways of working. With excellent influencing skills, you have an ability to foster relationships at all levels. You are pragmatic in your approach to how you challenge whilst ensuring compliance and best practice at all times.
Basic Requirements:
· Relevant Life Science / Business 3rd level qualification essential
· Experience in quality assurance within a regulated (pharmaceutical/medical device) industry with desirable
· Experience in the development and maintenance of ISO based quality systems desirable
· Experience in the training and assessment of staff in compliance, regulatory and quality standards
· Knowledge of review and appraisal of regulatory and/or legal documentation an advantage
· Ability to work independently and with self-direction
· Excellent interpersonal skills with a focus on the development of strong relationships internally as well as externally between partners, affiliates and suppliers
· Process driven with strong organisation skills a must
· Proven attention to detail and follow through
· Demonstrates initiative/Solutions oriented
· Flexible with a positive attitude towards change
· Proven ability to multitask in a pressurised environment in order to meet strict deadlines
· Computer literate in Word and Excel
· Excellent communication and people skills
· Experience of working on cross-functional teams
For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
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