Technical Specialist: Incidents

3 weeks ago


London, United Kingdom Adveniunt Medical International Ltd Full time

Adveniunt Medical International Limited (t/a Quality First International) seeks a technologist/scientist in medical device regulations.

Main duties & responsibilities:
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**:
A understanding of general and specific consumer protection laws is desirable.
- 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.

Permanent or settled status in the United Kingdom is required.

About us
Adveniunt Medical International Limited (t/a Quality First International) is a leading, global medical devices consultancy, with extensive insight and business know-how in the medical devices regulatory field. We are committed in solving regulatory, technical and compliance challenges to enable medical device to enter the global marketplace.

**Benefits**:
Permanent employment with 6 months’ probation period
28 days paid annual leave
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

References and proof of qualifications will be sought

**Job Types**: Full-time, Permanent

**Salary**: £25,000.00-£35,000.00 per year

Schedule:

- Monday to Friday

Ability to commute/relocate:

- London: reliably commute or plan to relocate before starting work (required)

Work Location: In person

Application deadline: 07/04/2023
Reference ID: 0000-230302-02


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