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Regulatory Affairs Manager
Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated
Regulatory Affairs Manager
to lead and oversee all regulatory compliance activities.
This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.
Regulatory Affairs Manager
Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated
Regulatory Affairs Manager
to lead and oversee all regulatory compliance activities.
This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.
Role/Responsibilities
Lead the
regulatory strategy
for new product introductions and support existing products through their full lifecycle.
Manage
regulatory submissions
(e.g. 510(k), CE Mark) and global product registrations.
Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe.
Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance.
Partner with Quality Assurance to ensure
post-market surveillance
and vigilance activities meet applicable standards.
Review and approve
promotional and advertising materials
from a regulatory perspective.
Identify and allocate internal and external resources needed to maintain a robust regulatory function.
Provide
strategic advice
and cross-functional support on all regulatory matters.
Candidate Requirements
Bachelor's degree in
Engineering
,
Life Sciences
, or a health-related field.
10+ years of experience
in the medical device industry, with a minimum of
3 years in a leadership or management role
.
In-depth knowledge of
US FDA
and
EU medical device regulations
(including MDR).
Proven ability to handle complex regulatory submissions and interactions.
Excellent
organizational
,
leadership
, and
communication
skills.
A self-starter with a
hands-on approach
and the ability to thrive in a dynamic, entrepreneurial environment.
Previous experience in an
SME or medtech startup
is highly desirable.
For further information please contact James Cassidy ****** or call in confidence ***********
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