Our client is specialized in HealthCare industry.
RESPONSABILITIES :
Responsible for EMEA quality and regulatory strategy development and execution.
- Take responsibility for a wide product range within EMEA Region from Quality and Regulatory Affairs perspective.
- Manage and lead the team members in charge of quality and regulatory affairs activities for the EMEA Region.
- Act as company representative in front of Competent Authorities and other external parties, for product post marketing surveillance purpose (vigilance and recall) and maintain/foster relationship with key stakeholders to facilitate interactions.
- Act as Quality Management Representative (“QMR”) and drive the quality planning, quality assurance, quality control and quality improvement-related activities in the entity.
- Act as Person Responsible for Regulatory Compliance (“PRRC”) for medical devices, as defined by the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
- Advice the business on quality and regulatory requirements for all products within the portfolio for pre- market to post-market phases.
- Ensure necessary quality planning, quality management, quality assurance and quality control activities are enforced.
- Coordinate and support product registration activities (strategic, tactical, and operational implementation) within EMEA region.
- Ensure and coordinate regulatory intelligence concerning our product portfolio within EMEA Region.
- Identify risk areas and develop mitigating action plans including anticipation of regulators responses through scenario planning and development of contingency plans for EMEA region.
- Ensure, coordinate and support auditing activities
PROFILE :
- Master’s degree in Life Sciences, natural sciences or pharmaceutical degree
- 8 years of direct experience in Regulatory Affairs (including product registration in EMEA) and Quality Management, including at least 1 year of professional experience in Regulatory Affairs or quality management systems relating to medical devices
- Comprehensive knowledge of EMEA regulations, current industry practices and strong experience with interpretation and application
- Experience in a regional role covering multiple locations/countries
- Experience in leading a team (direct and indirect) and solid experience in managing projects in matrix organization
- Training on ISO 9001 and/or ISO 13485 standards
- Comprehensive knowledge of EMEA regulations regarding life science products (medical devices, cosmetic products, food/food supplement and drugs ) minimum 2 out of 4 product categories
- Fluent in English (both written and spoken)
- Project management skills
- RAPS certification for drugs and/or medical devices is a plus
