Head of Quality Assurance and Regulatory Affairs - Stockton-on-Tees, United Kingdom - Jackson Hogg

Jackson Hogg

Verified Company

Stockton-on-Tees, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Head of Quality Assurance and Regulatory Affairs

Stockton-on-Tees

(Hybrid - 1 day/week on-site. Travel/accommodation expensed if based out of region)

Competitive Salary

Jackson Hogg are delighted to be partnering with a leading medical equipment manufacturer who are seeking to recruit a highly experienced Head of Quality Assurance and Regulatory Affairs join their Senior Leadership Team.

IBEX Innovations are dedicated to developing innovative X-ray imaging software to increase access to osteoporosis diagnosis and improve patient outcomes.

Reporting to the CEO, will be responsible for continually improving and managing the Quality Management system, guaranteeing it is compliant with ISO 13485, EU MDR and other regulatory markets to ensure the award of
CE marking and
FDA approval.

Skills and qualifications required:

Experience managing
CE marking and
FDA approval processes.
Experienced composing, reviewing, and maintaining compliance with regulatory files (technical files, documentation, 510 (K).
Specialist in medical device regulations (
MDR) and demonstrated performance when working with medical device quality management systems and/or regulatory affairs, particularly to software medical device standards.
Experienced working across various regulatory markets, including EU, US, UK and other relevant markets.
Effective project management experience and the ability to respectfully challenge and influence others (colleagues and stakeholders).
Use critical thinking to prioritise workflow and manage tasks.
Able to commence working with limited to no training required ability to work within a small team and independently.

Schedule: