Regulatory Affairs & Quality Manager - Medical Devices (m/w/d)

Job Title: Quality & Regulatory Specialist – IVDs Job Type: 12 month fixed term contract
Attractive salary and package

An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. The Regulatory Affairs & Quality Department primary role is to establish the Quality/Regulatory link between products and the end user. Reporting to the Chief Regulatory Affairs and Quality Officer, the Quality and Regulatory Affairs Specialist is responsible to deliver end to end regulatory package under ODM-Distributor scheme in compliance with established quality management system, overseeing (but not limited to) initial compilation of design control evidences, supplier management, incoming inspection and product release process, product submission, post-market surveillance, vigilance and associated reporting.

The role is responsible for maintaining product and site regulatory & quality compliance to maintain license/registration once granted.
The role is also responsible for supporting other regulatory and quality affairs team members as needed, including training and guidance as appropriate.
Preparing and compiling regulatory documentation, coordinating and executing regulatory submission in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements as appropriate.
Advising staff and project team members on data and information required for successful license applications and coordinating their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
Ensuring Quality Assurance release of incoming goods, intermediate and final product obligation.
Ensure Supplier management obligations.
Be a point of contact for regulatory & quality compliance issues.
Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
Support QMS organization during regulatory inspections or certifications audits.
Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 requirements.

Master’s degree or equivalent in life sciences and significant experience in a regulatory/quality role.
Experience in medical device / IVD / biotech industry.
Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, CMDR, etc).