This is a fantastic medical device company with offices in the UK and
in Ireland. Although still small-mid size they actually have the
backing of a larger pharma company so eventually could move into
combination products. This company are working on truly groundbreaking
stent technology which is the first of its kind. Having just opened a
brand new, state of the art office they are looking at adding another
**Apply on the website**% of their headcount over again in **Apply on
the website** so there has never been a better time to join the team!
RESPONSIBILITIES:
? Lead international regulatory submissions for products in
development. ? Manage submission timelines and risks. ? Review
data for submissions and provide feedback/recommendations on any gaps.
? Support CE Mark maintenance. ? Define the regulatory strategy
for projects in development.
REQUIREMENTS:
? 5 years experience in Regulatory Affairs. ? Experience in Class
IIb and/or Class III medical devices.? Technical competency of ISO
**Apply on the website**:**Apply on the website**, MDD **Apply on the
website**/**Apply on the website**/EEC, MDR **Apply on the
website**/**Apply on the website**, and the FDA QSRs is essential.?
FDA, PMDA and NMPA authority experience is important. To find out more
about this or any of our other projects, please get in touch with our
recruitment team. We are an equal opportunities Recruitment Business
and Agency. We welcome applications from all suitably qualified
candidates regardless of their race, sex, disability, religion/belief,
sexual orientation or age.
Planet Pharma is an Employment Agency providing Global Staffing
services. Location ? Galway Reports to ? Director of Regulatory Affairs
This is a fantastic medical device company with offices in the UK and
in Ireland. Although still small-mid size they actually have the
backing of a larger pharma company so eventually could move into
combination products. This company are working on truly groundbreaking
stent technology which is the first of its kind. Having just opened a
brand new, state of the art office they are looking at adding another
**Apply on the website**% of their headcount over again in **Apply on
the website** so there has never been a better time to join the team!
RESPONSIBILITIES:
? Lead international regulatory submissions for products in
development. ? Manage submission timelines and risks. ? Review
data for submissions and provide feedback/recommendations on any gaps.
? Support CE Mark maintenance. ? Define the regulatory strategy
for projects in development.
REQUIREMENTS:
? 5 years experience in Regulatory Affairs. ? Experience in Class
IIb and/or Class III medical devices.? Technical competency of ISO
**Apply on the website**:**Apply on the website**, MDD **Apply on the
website**/**Apply on the website**/EEC, MDR **Apply on the
website**/**Apply on the website**, and the FDA QSRs is essential.?
FDA, PMDA and NMPA authority experience is important. To find out more
about this or any of our other projects, please get in touch with our
recruitment team. We are an equal opportunities Recruitment Business
and Agency. We welcome applications from all suitably qualified
candidates regardless of their race, sex, disability, religion/belief,
sexual orientation or age.
Planet Pharma is an Employment Agency providing Global Staffing
services.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
