Responsibilities- Support the Mergers & Acquisitions team on assessing the regulatory and compliance gaps during due diligence phases, conduct Q&R Due Diligence - Perform Assessments on prospective M&A target companies - Co-ordinate (Project Manage) Revisions to the M&A Q&R Playbook - Evaluate feedback from M&A Playbook Users in order to identify improvements to the M&A Q&R process - Update M&A Q&R Playbook and associated Templates / Checklists, and M&A SharePoint as required Deliver M&A Q&R process training to Q&R community Coordinate and track M&A Q&R activities and progress as required - Present on Progress to the Q&R Leadership Team as required
Requirements- Bachelor’s degree or equivalent preferably in a scientific discipline - Minimum of 7 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry. - Proven experience in Quality Management System processes. - (Lead) auditor experience - A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. - This position requires an extensive knowledge of FDA QSR’s, ISO 13485, and other worldwide Quality System Regulations. - An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization - Skill set required for the department to operate: - Project management experience, desired - Good communication skills written & verbal in English - Demonstrated experience in collaborative working environments - Experience addressing conflicts, escalation at team level to achieve desired results. - Demonstrated experience handling deadlines, able to focus on targets - Demonstrated experience-driving progress, taking initiative to achieve results.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Robin Hiariej.