Senior RA Specialist Med Tech - Life Science - Global

This is an excellent opportunity to join an innovative and international Swedish medtech Company with high potential at an exciting time in its evolution.

Purpose of position:

• Responsible for regulatory strategy, guidance to organization on regulatory affairs matters throughout the life cycle of a medical device from product development, placing product on market and ongoing commercial supply and product maintenance for the company´s new and existing license partners
• Acting as the Regulatory Affairs Expert with new and existing license partners and ensuring compliance with laws and regulations set by the Healthcare products’ Regulatory Agencies

Detailed activities and responsibilities:

• To be the main contact for RA activities including participate in regular meetings with license partners
• Develop, create, submit and maintain product registrations for company´s products during new product development, line extensions for licensing activities
• Perform regulatory affairs review and approval of product labelling and marketing material for new products and licensing activities
• Creating and submitting changes or any other requested activities/documentation to regulatory agencies and respond to queries and request from those upon assignments
• Surveillance of new and changed regulatory requirements and guidance in key market areas such as EU and US, and to communicate such changes externally to our license partners when requested
• Responsible for maintaining technical files and the regulatory strategy for medical devices for license partners upon assignments

Report to Global Head of Quality & Regulatory Affairs

Are you interested please Contact Niklas Claesson