Senior Regulatory Specialist

 The purpose of this role is to provide and maintain regulatory support, supply regulatory input and data and ensure compliance with standards and medical device regulations worldwide.

• • Provide support for registration activity in your assigned geographic region(s) this includes (but is not limited to):
• o Developing registration and launch plans with the regional sales managers to ensure that
• o The preparation and submission of registration dossiers, and their submission and remediation.
• o Establish and maintain regulatory information systems such as technical documentation, quality records, routine reports and regulatory agency communications
• o Interpret existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures
• Ensure compliance to global regulatory requirements and company policies
• Provide input to Company activities including the risk management process, process and procedure improvements, management review and support new product development activities
• Review document and product changes for regulatory submission impact
• Support equipment, system and process development in-house and with suppliers
• Interface and co-ordinate with regulatory agencies; provide regulatory input and appropriate follow-up support to inspections and audits (e.g. FDA, Notified Bodies etc)