Job Details: Medical Device Regulatory Specialist


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Medical Device Regulatory Specialist
My client is currently looking to hire a Regulatory Specialist for
their medical device business. The role could be part-time or
full-time with the opportunity that the majority of the time could be
spent working from home.
The role:
Will see you providing Quality and Regulatory Compliance resources to
a wide range of medical companies. The role will mainly be dealing
with the administration of European Authorised Representative work and
dealing with client queries in respect of selling and distributing
medical devices in Europe. The role would also involve reviewing and
writing technical files (dependent on experience).
Generally, the role will encompass:

? Hosting Notified Body audits in the Dublin office

? Compiling documentation for Technical Files for regulatory
compliance

? Participation in Risk Assessments

? Liaising with suppliers to establish a supply chain

? Document assembly and test methods

? Working with electronics and software design and development
engineers

? Interpret and implement the requirements of EN/ISO standards
The Key

REQUIREMENTS:

The Medical Device Regulatory Specialist will be responsible for
managing a Medical Device Representation company so must be able to
communicate with managers and technicians across multiple
technologies. Generally, for this role, the company require:

? Ideally either 4 years? experience in Medical Device Regulations
for Europe MDD/MDR or one year experience with a relevant degree
(Minimum of PRRC Qualification)

? Ability to attend the Dublin office at short notice if required to
meet with auditors etc.

? It is essential to be multidisciplined and have an understanding
of mechanical engineering, electronics as well as software engineering

? Good knowledge of EN ISO **Apply on the website** and ideally a
lead auditor,

? Understanding and ability to implement UDI

? Understanding of European Representation requirements, SRN and
Eudamed

? Good administrator and manage other remote staff to maintain
client registrations in a timely manner

? Additional experience in IVD/IVDR an advantage

? Self-sufficient and able to grow the Irish company as well provide
a support overflow of business from the UK

? Ability to construct/oversee Technical Documentation for EU
including:
General Safety and Performance

_REQUIREMENTS_
Classification rationale
Risk Assessment
Usability
Software Life Cycle
Biocompatibility
Sterilisation, Packaging and Expiry date
Clinical Evaluation
Labelling including IFU
They offer:

? A very attractive remuneration package

? An immediate start

? The opportunity to work with a team of industry leading
professionals

? Flexibility to work full or part time and from home

? This role is likely to give the successful applicant the
opportunity to broaden their skills
To apply for this Medical Device Regulatory Specialist vacancy online,
please click on the ?Apply? button below. If, however, you would
like to discuss it prior to application then please contact Lee
Gosshawk at OSP Group My client is currently looking to hire a Regulatory Specialist for
their medical device business. The role could be part-time or
full-time with the opportunity that the majority of the time could be
spent working from home.
The role:
Will see you providing Quality and Regulatory Compliance resources to
a wide range of medical companies. The role will mainly be dealing
with the administration of European Authorised Representative work and
dealing with client queries in respect of selling and distributing
medical devices in Europe. The role would also involve reviewing and
writing technical files (dependent on experience).
Generally, the role will encompass:

? Hosting Notified Body audits in the Dublin office

? Compiling documentation for Technical Files for regulatory
compliance

? Participation in Risk Assessments

? Liaising with suppliers to establish a supply chain

? Document assembly and test methods

? Working with electronics and software design and development
engineers

? Interpret and implement the requirements of EN/ISO standards
The Key

REQUIREMENTS:

The Medical Device Regulatory Specialist will be responsible for
managing a Medical Device Representation company so must be able to
communicate with managers and technicians across multiple
technologies. Generally, for this role, the company require:

? Ideally either 4 years? experience in Medical Device Regulations
for Europe MDD/MDR or one year experience with a relevant degree
(Minimum of PRRC Qualification)

? Ability to attend the Dublin office at short notice if required to
meet with auditors etc.

? It is essential to be multidisciplined and have an understanding
of mechanical engineering, electronics as well as software engineering

? Good knowledge of EN ISO **Apply on the website** and ideally a
lead auditor,

? Understanding and ability to implement UDI

? Understanding of European Representation requirements, SRN and
Eudamed

? Good administrator and manage other remote staff to maintain
client registrations in a timely manner

? Additional experience in IVD/IVDR an advantage

? Self-sufficient and able to grow the Irish company as well provide
a support overflow of business from the UK

? Ability to construct/oversee Technical Documentation for EU
including:
General Safety and Performance

_REQUIREMENTS_
Classification rationale
Risk Assessment
Usability
Software Life Cycle
Biocompatibility
Sterilisation, Packaging and Expiry date
Clinical Evaluation
Labelling including IFU
They offer:

? A very attractive remuneration package

? An immediate start

? The opportunity to work with a team of industry leading
professionals

? Flexibility to work full or part time and from home

? This role is likely to give the successful applicant the
opportunity to broaden their skills
To apply for this Medical Device Regulatory Specialist vacancy online,
please click on the ?Apply? button below. If, however, you would
like to discuss it prior to application then please contact Lee
Gosshawk at OSP Group

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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