Regulatory Affairs and Quality Control Manager

Purpose:
To ensure we are fully compliant with current and future regulatory requirements.

Whilst reporting to our Operations Manager, you will be responsible for managing ISO13485:2016, GDP, Technical Files for CE marking, all SOP’s and company procedures.

Skills/Attributes Required:
Strong analytical, organisational, and time and task management skills
Excellent verbal and written communication skills, reporting skills, administrative skills and attention to detail
Excellent clerical and keyboard skills
Enthusiastic and dependable, focused and goal oriented
Excellent team working, motivational, interpersonal and communication skills
Full understanding of all regulatory requirements
Ability to work under pressure and meet deadlines

Education/Experience Required:

Essential:
Minimum 5 years work experience in regulatory and quality management
University entrance A level or equivalent qualifications
Computer literacy, IT skills, and keyboard skills.  Proficiency with MS Office Suite, particularly MS Word, Excel and PowerPoint
Experience with ISO13485, GDP and quality
Awareness of legislation relevant to medical devices and GDP

Better With:
A Bachelor’s or Associate’s degree in a relevant field
Previous experience or knowledge of healthcare sector

Certifications/Licenses Required:
Driving Licence

Primary Responsibilities:
Maintain integrity of QMS/GDP files ensuring consistent processes are established and implemented and independent certification is maintained