BRIEF COMPANY PROFILE

THE POSITION

POSITION PROFILE

• Part of the Senior Leadership Team of Our client.
• Part of the Global RA/QA Leadership Team of Radiometer.
• Leading the RA and QA strategy development, planning, and implementation.
• Developing and implementing policies to ensure ongoing compliance of regulatory requirements.
• Defining, documenting, implementing, maintaining and improving the quality management system – and maintaining its effectiveness in accordance with Radiometer and the requirements defined in ISO 13485, Quality System Regulation (FDA), and other relevant national and international requirements.
• Ensuring that necessary RA/QA resources are represented in all relevant R&D, Operations, and Sales activities – such as, but not limited to:
  • Supporting R&D in delivering right documents in the right quality.
  • Ensuring product registration according to Sales priority list.
  • Supporting Operations in execution of products and in process validation.
• Managing, leading and mentoring the RA/QA organization.
• Ensuring smooth and efficient workflows within and across each of the RA/QA teams.
• Identifying and mitigating risks and developing alternative courses of action, including anticipation of regulators responses through scenario planning and development of contingency plans.
• Anticipating regulatory and quality related obstacles, and emerging issues throughout the product lifecycle.
• Ensuring that all necessary authorizations, variations and certificates etc. on new and existing products are obtained, maintained and in legal compliance.
• Ensuring that regulatory and quality input for follow-up to inspections and audits are provided.
• Ensuring competent representation of regulatory affairs and quality assurance in product recall and recall communication processes, hereunder deciding upon field action and reportable events to ensure regulatory compliance.
• Ensuring that adverse events are reported to regulatory agencies and internal stakeholders.
• Ensuring adequate internal reporting on quality and environmental indicators, activities, results and nonconformities.

• Successfully building increased commercial and performance management awareness in RA/QA team.
• Ensuring readiness for FDA inspection(s).
• Successfully delivering on QA-related KPI’s, including among others NCR/CAPA’s, QMS compliance, doc control, complaints, design control, validations etc.
• Successfully delivering on RA-related KPI’s, including among others product life cycle submissions, notifications, variations, reviews, safety etc.
• Successfully driving a high-performance culture focused on adding value in alignment with the business and talent management.
• Achieving operational excellence within RA/QA by ensuring that the right capabilities, structures, systems and processes are in place.

CANDIDATE PROFILE

• 7+ years of experience from the Medical Devices industry
• 5+ years of experience with Quality and Regulatory Management of medical devices.
• 5+ years of experience as a manager (and preferably managing managers) building people, teams and organizations based on relentlessly attracting, engaging and developing people.
• Excellent understanding of regulatory demands, including ISO-13485 and QSR.
• Preferably multi-site experience.
• Experience with “charting the course” for a RA/QA team managing vision and purpose while demonstrating strategic agility.
• Strong track record of “driving innovation and growth” in an international setting responding to customer needs while advancing new ways of thinking in the team.
• Preferably in-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA, ISO and MDD).
• Proven track record with problem solving and continuous improvements.
• Good working knowledge of IT tools and specifically Quality Management systems.