Healthcare Compliance Officer

Healthcare Compliance Officer

At Staffline Recruitment we are working on behalf of our client, a leading healthcare company, who is seeking to recruit a Healthcare Compliance Officer to take up a maternity leave contract within their team.

The purpose of this role will be to drive the management and maintenance of the organisation's Quality Management and regulatory systems. The successful candidate will provide compliance an quality assistance to the highest international standard, across a broad range of areas including ISO and Health Care Compliance. This s an exciting opportunity to work for a company whose focus is in developing it's people and ensuring they are equipped to provide service solutions to it's customers.

Key responsibilities will include:

• Healthcare Compliance - Lead and drive 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, etc
• 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

Interested candidates will meet the following 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
• Proven attention to detail and follow through
• Demonstrates initiative/Solutions oriented
• Proven ability to multitask in a pressurised environment in order to meet strict deadlines
• Excellent communication and people skills

If you meet the above requirements and are available to take up a contract position, Please send an up to date version of your cv to Laura Craughwell at Staffline Recruitment via the enclosed link.

This contract position will offer a salary in the region of €55,000 - €60,000 plus completion bonus and a hybrid working model.