Job Details: Sr. Regulatory Affairs Specialist


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Sr. Regulatory Affairs Specialist
Location: Not Specified

Senior Regulatory Affairs Specialist

My client is a highly desirable Medical Device design and
manufacturing company in Galway, and is commutable from parts of Clare
and Mayo. There&#**Apply on the website**;s a new vacancy for a Senior
Regulatory Affairs Specialists who will be directly involved in
regulatory activities supporting the global commercialization and
sustaining of products on the market in compliance with all regulatory
requirements. This role would suit someone with strong Regulatory or
QP experience and looking for up into a role where you can really make
an impact on the department.

About the role:

? Directs and influences the preparation of documentation to support
high quality regulatory submission dossiers.

? Engages with global international regulatory partners to support
regulatory strategy for new products/therapies and changes to existing
products. Partners with engineers and technical experts to develop
robust regulatory strategies and resolve questions from regulatory
agencies.

? Engages with global regulatory agencies representing the company
and ensuring the voice of the regulator is considered in developing
global regulatory strategies.

? Leads regulatory filings to support submissions, license renewal
and annual registrations.

? Influences clinical evidence strategy to support labelling
content, marketing claims and regulatory compliance.

? Support manufacturing strategy via a robust change control
approach to ensure global approval and implementation of product and
process changes

? Mentors and coaches other employees within the department and
provides leadership support to ensure strong talent development.

? Keeps abreast of regulatory procedures and changes. Supports
industry advocacy activity to shape the future of evolving regulatory
requirements. Develops internal procedures to ensure continuous
compliance with all regulatory requirements.

? Develops strategies for earliest possible global approvals of
regulatory filings.

? Supports regulatory compliance activities, including manufacturing
site registration & GMP audits as needed.

? Identifies and develops best practices within the Regulatory
Affairs Department including continuous development initiatives.

Personal attributes of the successful candidates:

? Recognized expert, capable of managing large projects or
processes.

? Dynamic team player and can work effectively and pro-actively on
activities both individually and in teams.

leader.

? Strong coach/mentor and can provide coaching/training to other
employees within the RA Department.

Required Experience:

? Qualified Person or Bachelor&#**Apply on the website**;s
Degree/Masters in Science, Engineering or similar.

? 7+ years of Regulatory experience in Medical Devices and/or
Pharmaceuticals is essential.

For further information on this Senior Regulatory Affairs Specialist
role in Galway, please contact Marchon Monroe on (phone number
removed) /

Check out all our open jobs on our HERO Recruitment website - (url
removed)

Please Note: Under its obligation under the Data Protection
legislation, HERO Recruitment will not forward your details to any
company without your prior approval Location: Not Specified

Senior Regulatory Affairs Specialist

My client is a highly desirable Medical Device design and
manufacturing company in Galway, and is commutable from parts of Clare
and Mayo. There&#**Apply on the website**;s a new vacancy for a Senior
Regulatory Affairs Specialists who will be directly involved in
regulatory activities supporting the global commercialization and
sustaining of products on the market in compliance with all regulatory
requirements. This role would suit someone with strong Regulatory or
QP experience and looking for up into a role where you can really make
an impact on the department.

About the role:

? Directs and influences the preparation of documentation to support
high quality regulatory submission dossiers.

? Engages with global international regulatory partners to support
regulatory strategy for new products/therapies and changes to existing
products. Partners with engineers and technical experts to develop
robust regulatory strategies and resolve questions from regulatory
agencies.

? Engages with global regulatory agencies representing the company
and ensuring the voice of the regulator is considered in developing
global regulatory strategies.

? Leads regulatory filings to support submissions, license renewal
and annual registrations.

? Influences clinical evidence strategy to support labelling
content, marketing claims and regulatory compliance.

? Support manufacturing strategy via a robust change control
approach to ensure global approval and implementation of product and
process changes

? Mentors and coaches other employees within the department and
provides leadership support to ensure strong talent development.

? Keeps abreast of regulatory procedures and changes. Supports
industry advocacy activity to shape the future of evolving regulatory
requirements. Develops internal procedures to ensure continuous
compliance with all regulatory requirements.

? Develops strategies for earliest possible global approvals of
regulatory filings.

? Supports regulatory compliance activities, including manufacturing
site registration & GMP audits as needed.

? Identifies and develops best practices within the Regulatory
Affairs Department including continuous development initiatives.

Personal attributes of the successful candidates:

? Recognized expert, capable of managing large projects or
processes.

? Dynamic team player and can work effectively and pro-actively on
activities both individually and in teams.

leader.

? Strong coach/mentor and can provide coaching/training to other
employees within the RA Department.

Required Experience:

? Qualified Person or Bachelor&#**Apply on the website**;s
Degree/Masters in Science, Engineering or similar.

? 7+ years of Regulatory experience in Medical Devices and/or
Pharmaceuticals is essential.

For further information on this Senior Regulatory Affairs Specialist
role in Galway, please contact Marchon Monroe on (phone number
removed) /

Check out all our open jobs on our HERO Recruitment website - (url
removed)

Please Note: Under its obligation under the Data Protection
legislation, HERO Recruitment will not forward your details to any
company without your prior approval

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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