Senior Manager Regulatory Affairs for Medical Devices and Person Responsible
Vectura Ireland Limited is seeking a Senior Manager in Regulatory Affairs for Medical Devices who will also assume the critical role of Person Responsible for Regulatory Compliance (PRRC). This position plays a key role in ensuring compliance with European medical device regulations as Vectura's Authorized Representative. The successful candidate will also contribute to global regulatory strategy and drive the approval process for all medical device submissions, ensuring that Vectura's corporate goals are achieved.
Principal Accountabilities:
1. As Person Responsible for Regulatory Compliance (PRRC):
* Ensure full compliance with the Medical Device Regulations (MDR) in your capacity as PRRC for the European Authorized Representative.
* Lead communications and interactions with Competent Authorities regarding Vectura's duties as Authorized Representative.