
Did you know that your Internet Explorer is out of date?
To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.
![]() Google Chrome |
![]() Internet Explorer |
![]() Mozilla Firefox |
![]() Opera |
Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Galway
Carlow
Galway
Galway
Connaught
Tipperary
Limerick
Galway
Carlow
Carlow
Carlow
Galway
Galway
Westmeath
Galway
Dublin
Waterford
North Leinster
Galway
Westmeath
Dublin
Dublin
Westmeath
Dublin
Dublin
Dublin South
Clare
Dublin
Dublin
Galway
Galway
Carlow
Carlow
Galway
Republic of Ireland
Roscommon
Cork
Galway
Dublin
Republic of Ireland
Galway
Athlone
Cavan
Galway
Dublin
Dublin
Cork
Dublin
Dublin
Dublin
Dublin
Galway
Galway
North Leinster
Dublin
Galway
Tipperary
Athlone
Dublin
Galway
Dublin
Connaught
Dublin
Carlow
Galway
Dublin
Dublin
Dublin
Dublin
Dublin
Galway
Dublin
Dublin
Galway
Roscommon
Dublin
Athlone
Clare
Dublin
Meath
Athlone
Galway
Dublin
Dublin
Dublin
Dublin
Galway
Dublin
Carlow
Dublin
Dublin City Centre
Galway
Dublin
Galway
Limerick
Dublin
Galway
Republic of Ireland
Wexford
Leitrim
Galway
Meath
Republic of Ireland
Limerick
Dublin
Athlone
Germany
Galway
Galway
Galway
Galway
Clare
Carlow
Galway
Carlow
Limerick City
Galway
Galway
Galway
Dublin
Dublin
Galway
Leitrim
Galway
Dublin
Dublin
Dublin
Dublin South
Clare
Dublin
Tipperary
Dublin
Dublin
Dublin
Wexford
Dublin
Dublin South
Dublin
Dublin
Clare
North Leinster
Athlone
Galway
Leitrim
Galway
Tipperary
Dublin North
Galway
Limerick
Galway
Dublin
Athlone
Galway
Galway
Clare
Dublin
Tipperary
Carlow
Limerick
Longford
Dublin
Leitrim
Dublin
Carlow
Galway
Dublin
Carlow
Cork
Carlow
Galway
Galway
Galway
Carlow
Carlow
Galway
Meath
Dublin
Athlone
Athlone
Athlone
Galway
Galway
Carlow
Galway
Republic of Ireland
Dublin
Clare
Republic of Ireland
Connaught
Connaught
Dublin
Clare
Galway
Athlone
Galway
Dublin
Galway
Tipperary
Limerick
Athlone
Dublin
Galway
Galway
Dublin
Galway
Dublin
Galway
Meath
Galway
Athlone
Tipperary
Galway
Dublin
Republic of Ireland
Clare
Galway
Republic of Ireland
Dublin
Dublin
Kilkenny
Limerick
Dublin
Dublin
Dublin
Cavan
Dublin
Dublin
Galway
Clare
Dublin
Clare
Leitrim
Galway
Limerick
Galway
Connaught
Wexford
Dublin
Tipperary
Dublin
Athlone
Galway
North Leinster
Galway
Galway
Carlow
Dublin
Galway
Galway
Republic of Ireland
Athlone
Dublin
Dublin
Athlone
Galway
Roscommon
Galway
Dublin
Dublin
Galway
Galway
Dublin
Galway
Dublin
Galway
Galway
Leitrim
Carlow
Dublin
Galway
Canada
Dublin
Carlow
Canada
Dublin
Clare
Carlow
Meath
Galway
Dublin
Senior Regulatory Affairs Specialist
Reference: | TG - SRA Post Market | Location: |
Athlone Clare Connaught Galway Galway City Leitrim Limerick Limerick City |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
Job title: Senior Regulatory Affairs Specialist – Post market
Location: Parkmore, Galway. 1-2 days a week on site
Benefits: Top salary, Bonus, pension, healthcare, hybrid working
Overview:
My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Senior Regulatory Affairs Manager, the Senior Regulatory Affairs SpecialistPost Market will play a key role in the implementation of post-market activities. This is a fantastic opportunity, which will allow the successful candidate to add real value to the future success of the company.
Responsibilities:
- Responsible for the implementation of PMS activities identified under Post Market Regulatory Reporting and change assessment as defined in relevant Quality System procedures and Work Instructions.
- Approval of Vigilance/MDR reporting as defined in each territory.
- Support and lead Regulatory Post Market System improvements.
- Participate in the implementation of Field Safety Corrective Action plan and associated activities if required.
- Manage RA activities for Design Changes and Supplier-related changes including reporting assessment and generation of regulatory submissions.
- Provide RA Support to relevant Design Teams for Key Projects identified by Veryan.
- Provide support to other RA Specialists in achieving success for the team.
- Manage and support trend data for regulatory reporting.
- Management of PMA Annual Periodic Reporting system and approval of annual documentation for submission to FDA.
- Manage post-market scheduling of RA activities for timely completion and submission to regulatory authorities.
- Review and approval of RA QMS procedures and work instructions and ensure activities are performed in line with these.
Requirements:
- A degree level qualification in Engineering, Science, QA, or related field is essential.
- A minimum of five years experience at a senior regulatory level in the medical device industry is essential.
- A minimum of five years’ experience in the creation of regulatory submissions for premarket approval is required.
- Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
- Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.
Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR [email protected]
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS






