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Senior Regulatory Affairs Specialist - Medical Devices (Permanent)

LOCATION
Ireland , Ireland
APPLY BY
Expired
SALARY
€60,000.00 (per Annum) - €80,000.00 (per Annum)
APPLICATIONS
0 People

Nonstop Recruitment are currently working with a global client who are based in 100 countries and are one of the biggest medical technology in the world who create specialised medial devices, solutions and systems to help the healthcare industry and their needs.

The site in Ireland has been on that site for 50 years and looking to bring on a new Senior Regulatory Affairs Specialist to join their team. Currently they are seeking a passionate individual to come to the company and join one of the biggest companies in the world.


As a Senior Regulatory Affairs Specialist you will be responsible for a broad range of projects for infusion pumps, embedded and stand alone software, accessories for pumps or the infusion sets. You will participate in cross - functional teams as the regulatory expert.


Main Responsibilities include:
* Developing Regulatory strategies and provides guidance and expertise
* Communicates and complies the regulatory requirements (MDR, MDD)
* Reviews and also approves the project documentation which will include design reports and labelling etc..
* Updates to the technical files and the international registrations are conducted appropriately
* Develops tactics supporting first to market commercial opportunities and also minimise the time to product launch.
* Works closely with the other functions which include QA, R&D and medical affairs.
* Ensure that all regulatory requirements are effectively addressed within the documentation.
* Make sure that roadblocks are identified; problems are defined on data/fact and communicate effectively with your peers.
* Support the continuous improvements in the Regulatory processes.


Qualifications:
* BSC in electronics or Bio-medical engineering discipline or proven experience
* Minimum of 7 years experience with Regulatory Affairs Medical Devices and exposure to electrical programming equipment.
* Must have knowledge in MDR, MDD and FDA also the European Regulations.
* Knowledge in ISO13485, ISO 14971 and IEC 60601.
* Experience in representing Regulatory Affairs in multiple environments.


Skills:
* Analytical and planning skills and the ability to take decisions and to translate those decisions in the actions.
* Interpersonal skills which include strong communication and negotiation skills.
* Open minded and flexibility to work effectively in a dynamic multinational, matrix organisation.
* Open to travel (EU and outside EU)


If you feel that you are suitable candidate for this role with the relevant experience. Please apply with a word copy of your CV.


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