What you will be doing:
* Be part of the company management team with responsibility to lead regulatory strategy planning for company products.
* Responsible to prepare regulatory submissions across all products and platforms as needed.
* Review and present to the management and CEO regulatory updates and status reports.
* Responsible for the development and preparations of regulatory submissions across all products and platforms as needed.
* Be the point of contact for all regulatory inputs and deliverables from headquarters for product and clinical research submissions.
* Responsible for maintenance of product regulatory files and registrations (NoC, registration renewals, annual reports etc.).
* Provide regulatory support to R&D - project regulatory requirements, assure adherence to the regulatory path and resolve emerging conflicts with regulatory requirements.
* Responsible to provide regulatory support to manufacturing, logistics, engineering, supply chain and sales teams.
* Responsible for regulatory assessment of customer complaints, reportability assessments and MDR’s to regulatory agencies.
* Act * as the person responsible for regulatory compliance (PRRC), responsible to ensure the following:
* The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
* All post market surveillance and reporting obligations are met, including reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions and analysis of vigilance data.
* For investigational devices projects , the statement referred to in Section 4.1 of Chapter II of Annex XV of the EU medical device regulation (MDR) is issued. * This is a joint responsibility with VP of Global QA, where VP RA is the main responsible for the above activities
Requirements: What you have:
* B.S. or B.A. degree in a scientific or technical discipline. Advanced degree preferred.
* 15+ years of successful experience in regulatory affairs
* At least 5 years in a similar role, including people management
* A minimum of 8 years of Regulatory Affairs experience with the US FDA Class III and/or Class II medical devices
* Must have experience with regulatory registration and submissions in markets such as EU, China and US.
This position is open to all candidates.