Main duties:

As Technical Specialist, you will be involved in reviewing and evaluating medical device technical documentation, working with a variety of medical device manufacturers globally, including advising colleagues in your areas of competence with a commitment to delivering diligent and timely service. As Technical Specialist, you will be involved in market surveillance activities, principally notifications of adverse incidents on medical devices in UK, EU and other markets, supporting a variety of medical device manufacturers globally, product recall, field action, including safety corrections, removals and withdrawals support on behalf of clients.

Responsibilities include:

·   Assess adverse incident and market action reports, notices and documentation, evaluate and complete notification forms; process and submit reports to relevant market authorities, fulfilling regulatory requirements,

·   Complete and process product decal field actions, including safety corrections, removals and withdrawals, including communication with enforcement and competent authorities, other market supervisory authorities and trading standards

·   Investigate adverse incident and market action origin, causation and root cause, advise clients accordingly; produce necessary hazard evaluation and other supporting reports,

·   Examine/produce complaint evaluations on behalf of clients,

·   Prepare medical device and accessory equipment risk, impact and medical device assessments, including notification techniques and duties within documented QMS,

·   Assist with UK, European and global technical and medical device legislation, standards, guidance and industry codes,

·   Advise incoming legislation, standards, guidelines, safety codes and customer practices,

·   Investigate medical device adverse incident within the medical device sector, ensuring specific reporting timelines are met and that customers, regulatory bodies and notified/assessment bodies are informed,

·   Support industrial and/or technology research and consultancy programmes,

·   Write policies, procedures and work instructions plus other management system and regulatory control documents

Requirements:

The ideal candidate will be experienced in investigating failure, malfunction of medical device and related technology events.

You must demonstrate and apply significant knowledge and extensive experience you have gained in research, design and development or regulation of medical devices, including application of principles in design controls, risk management and performance or clinical evaluation. Familiarity with applied safety and reliability engineering techniques, benefit: risk assessments and clinical data evaluation would be advantageous. Strong scientific and technical writing skills are essential.

Comprehensive understanding and practical application of MDD, MDR, CE marking and MEDDEV 2.7/1 Clinical Evaluation of medical devices, MDCG and IMDRF guidance and ISO or IEC standards (eg, ISO 9001, ISO 13485, ISO 27001, ISO 14971 and IEC 60601 and Designated and Harmonised counterparts) is necessary. Familiarity with relevant medical device legislation, standards and industry codes is desirable, including UK, European and global. Familiarity with Safety Gate, Product Safety Database and other rapid exchange investigation and notification is desirable.

A understanding of general and specific consumer protection laws is desirable.

The successful candidate must be efficient, capable of unsupervised and directed grounded- and other research, proficient in Microsoft® Office and, familiar with medical device regulatory databases, produce scientific and technical reports and presentations. Experience in quality assurance and market surveillance methods used within the medical device industry would be advantageous.

At least 2 years’ experience in a similar role relating to medical devices regulatory / quality assurance is desirable. Excellent planning, organisational, listening, verbal, written communication and IT skills are essential. Strong interpersonal communication skills and meticulous attention to detail are essential. Candidates will be fluent in English and ideally in at least another European language or Mandarin. Travel and on-site duty at clients in the United Kingdom and abroad will be required periodically.

Permanent or settled status in the United Kingdom is required.

The ideal candidate will be capable of working to deadlines, able to respond to variable project and client requirements and remain productive.

Benefits

1. Permanent employment with 6 months’ probation period
2.  28 days paid annual leave
3. Training and development opportunities

Working hours Monday to Friday, generally from 9 am to 5 pm with occasional out of hours working required. Start date ASAP.

Please email your curriculum vitae clearly marked with the position title and your name in the subject title of your email.

References and proof of qualifications will be sought

Job Type: Full-time

Salary: negotiable, subject to qualifications, proficiency and experience

If you think that you possess the skills that QFI seeks, please send us a copy of your Curriculum vitae and cover letter via email to jobs@qualityfirstint.com.