specialising in the manufacture of medical device coatings.
Role: Senior Regulatory Affairs Specialist
Location: Galway
Contract: An initial 6 month hourly rate contract
Your role as a Senior Regulatory Affairs Specialist, will be to
coordinate, prepare, and maintain regulatory submissions on a global
level including European CE-marking and US FDA submissions.
Responsibilities:
Ensure regulatory compliance for assigned product lines.
Prepare regulatory submissions to regulatory authorities and/or
distributors.
Maintain expertise in worldwide regulatory requirements, with an
emphasis on MDR.
Maintains and enhances cross-functional team relationships.
Participate in and assists with Notified Body Audits.
Provides support for commercialized products as necessary by reviewing
labelling, promotional materials, and product and documentation
change.
Requirements:
Degree in Engineering / Science Discipline.
6+ years experience within the medical device industry.
Keen attention to detail.
Ability to work cross functionally.
Proven communication skills.
No CV ready? Not sure yet? Feel free to contact me for further
details.
This is an excellent opportunity to work within a global medical
device company, within an exciting Regulatory team.
Please click to find out more about our Key Information Documents.
Please note that the documents provided contain generic information.
If we are successful in finding you an assignment, you will receive a
Key Information Document which will be specific to the vendor set-up
you have chosen and your placement.
To find out more about Real please visit
Real Staffing, a trading division of SThree Partnership LLP is acting
as an Employment Business in relation to this vacancy| Registered
office | 1st Floor, **Apply on the website** King William Street,
London, EC4N 7BE, United Kingdom | Partnership Number | OC(phone
number removed) England and Wales The company are a globally recognised medical device company,
specialising in the manufacture of medical device coatings.
Role: Senior Regulatory Affairs Specialist
Location: Galway
Contract: An initial 6 month hourly rate contract
Your role as a Senior Regulatory Affairs Specialist, will be to
coordinate, prepare, and maintain regulatory submissions on a global
level including European CE-marking and US FDA submissions.
Responsibilities:
Ensure regulatory compliance for assigned product lines.
Prepare regulatory submissions to regulatory authorities and/or
distributors.
Maintain expertise in worldwide regulatory requirements, with an
emphasis on MDR.
Maintains and enhances cross-functional team relationships.
Participate in and assists with Notified Body Audits.
Provides support for commercialized products as necessary by reviewing
labelling, promotional materials, and product and documentation
change.
Requirements:
Degree in Engineering / Science Discipline.
6+ years experience within the medical device industry.
Keen attention to detail.
Ability to work cross functionally.
Proven communication skills.
No CV ready? Not sure yet? Feel free to contact me for further
details.
This is an excellent opportunity to work within a global medical
device company, within an exciting Regulatory team.
Please click to find out more about our Key Information Documents.
Please note that the documents provided contain generic information.
If we are successful in finding you an assignment, you will receive a
Key Information Document which will be specific to the vendor set-up
you have chosen and your placement.
To find out more about Real please visit
Real Staffing, a trading division of SThree Partnership LLP is acting
as an Employment Business in relation to this vacancy| Registered
office | 1st Floor, **Apply on the website** King William Street,
London, EC4N 7BE, United Kingdom | Partnership Number | OC(phone
number removed) England and Wales
We need : English (Good)
Type: Permanent
Payment:
Category: Others
