To ensure and maintain regulatory compliance with the Medical Device Directive, CE Marking Regulations and all other applicable external Regulations & Standards and internal quality processes.
To identify and document processes ensuring regulatory and ISO compliance.
Main Duties and Responsibilities:
* To ensure Medical Device Directive (93/42/EEC) compliance by:
Ensuring all Essential Requirements of the MDD are met in full,
Ensuring that Technical Files are built, populated and maintained to demonstrate compliance with the Medical Device Directive.
To ensure that products are CE marked and that supporting documentation is sourced, collated and maintained.
To identify, document, & implement procedures designed to ensure compliance with the Medical Device Directive & CE Regulations (based on ISO 13485/ISO 9001).
Support work on for products and specifications respect of Quality.
Assist in maintaining ISO Standards & other quality standards as appropriate for the business.
Assist in maintaining Regulatory compliance as appropriate for all companies within the Group.
Ensure quality processes are maintained throughout the Group to the appropriate standard required.
Undertake the job in line with the Company appraisal competencies as follows:
Achieves business results and adds value to the Company
Focuses on internal / external customers
Builds and maintains effective teamwork with colleagues
Embraces change and deals with ambiguity
Perform duties according to all Company policies, procedures and instructions.
This job description shall not limit your role, you will also be expected to carry out any other duties that your Manager feels are within your capabilities and skill set. The above information may not cover everything involved in the position but indicates the size and scope of the role and may be subject to change as the role develops.
Key Performance Indicators:
Person Required:
Computer literate with a good working knowledge of Microsoft Office applications.
Thorough and attentive to detail.
Ability to write clear, concise procedures and Policies.
Knowledge:
Good working knowledge of:
a)Class 1 Medical Device compliance
b)ISO 13485:2003 or ISO 9001:2008
Experience:
The Candidate must have experience in working in the Medical Device sector or similarly regulated business.
The Candidate must have experience in process documentation.
Qualifications:
Ideally trained in Medical Device compliance,
Ideally trained as an Auditor.
Other:
An enthusiastic and self motivated individual who strives to succeed. Must be flexible, adaptable and positive in their approach to work.
Confident and able to interact with all levels of management.
To apply for this position, candidates must be eligible to live and work in the UK
Matchtech is acting as an Employment Business in relation to this vacancy.