Job Ref: 213733966

Date: 2021-05-12 12:01:02

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Our client a fast-growing Medical Devices company based in Buckinghamshire is recruiting for an experienced Regulatory Affairs Specialist to join their team where you will be working directly with the QARA Manager (Heads the Team) + QA Manager and QA Specialist, in total a team of 4.

Our clients’ products need to be MDR compliant within a very niche market a lot of what they do is extremely complicated, so they need someone who can communicate at all levels, both written and spoken English is important.

The ideal candidate for this role will have the following experience and expertise.

* Medical Device experience and ideally auditing experience to ISO13485 standard

* MDD, MDR, Tech files, FDA HCanada, CE Marking, Device Registrations

ROLE OVERVIEW:

As RA Specialist you will support the QARA Manager and be the crucial link between new and current products and regulatory authorities. You will combine your knowledge of Regulatory Assurance, Quality Assurance along with scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by our client, meet the required legislation.

ESSENTIAL DUTIES & RESPONSIBILITIES:

Regulatory support of Class IIa and IIb Medical Devices including:

* Maintenance of the Technical Files (documentation) for existing brands

* Regulatory strategy development

* Timely device registrations / maintenance

* Through active support of the QA Manager drive;

* Compliance with the regulatory requirements of MHRA, EU(CE), FDA, Health Canada, TGA.

* Compliance with ISO 13485, ISO 9001

* To progress to be the

* PRRC (Person Responsible for Regulatory Compliance),

* Company Officer responsible for meeting CMDR quality system requirements and also for authorising changes and Health Canada license changes.

* Support new product development and continuing engineering projects, assuring project deliverables are met and are compliant with relevant regulations and standards.

* Drive a culture of quality and regulatory compliance throughout the business.

* Implement changes from new or updated regulations/standards

* Contribute to the team spirit and continual improvement within the company and undertake any other reasonable task considered appropriate by Senior Management.

* Make suggestions for changes and improvements and how to implement them

* Using relevant tools and ensure managers and other staff understand how to improve the business

KNOWLEDGE, SKILLS & EDUCATION TO BE SUCCESSFUL IN THE JOB:

Education Required:

A degree or higher national diploma (HND) in any subject.

Education Preferred:

A degree or higher national diploma (HND) in any

subject.

Years of related experience:

Several years’ experience as a Senior/ Principal Quality

Manager in the medical device/medical service industry.

Familiar or have worked with US FDA 21 CFR 820, EU MDD 93/42/EEC.

Quality Management Representative experience

Special Skills/Abilities:

US FDA Current Good Manufacturing Practice (CGMP)

Lead auditor – ISO 13485.

MDR, Risk Management, CE Marking of Medical Devices.

OTHER REQUIREMENTS:

* Self-starter

* All round proficiency in communication

* Organisational skills

* Presentation skills

* Results driven.

* Strategic thinking

* Leadership skills

PHYSICAL AND OTHER REQUIREMENTS:

* Travel is required occasionally for this position.

* Ability to sit and use a computer for extended periods of time; ability to answer phones and utilise a variety of office equipment

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