RA Assistant Manager

Typical Duties:

▫ Survey, analyze regulations, regulatory guidance and standards; monitor changing regulations, assess impact and provide feedback

▫ Assist in the development of Company RA policies; develop procedures compliant with these policies, regulations, regulatory guidance and standards

▫ Support Company regulatory awareness and implementation of policies and procedures

▫ Develop and validate regulatory strategy and ensure consistency at system and global levels; adapt to evolving regulations, technology and products

▫ Assess regulatory compliance of third party products and of their suppliers; assist in due diligence and in the development and review of supply agreements

▫ Influence and negotiate with external stakeholders and regulatory agencies

Other tasks as defined in related company procedure, or assigned by the direct supervisor.

Skill/Educational requirements:

▫ Developed knowledge and understanding of regulatory requirements, guidance documents and processes with around 10 years of practice in the field of IVD/MD in an international environment.

▫ Knowledge of change impact assessment, device EMC certification, SW registrations and change controls.

▫ Familiar with product profiles, technology and history, with company organization and processes

▫ Familiar with local regulatory agency organization, rules and key personnel

▫ Participation in professional, trade and standard organizations

▫ Can work in an international environment

▫ Mentor and share experience, complex issue analysis and problem solving

▫ Communicate to internal/external stakeholders, regulatory agencies or their representatives

▫ Influence, challenge and negotiate